Diabetes Mellitus, Type 2
Conditions
Keywords
pharmacokinetic, intestinal bile acid transporter inhibitor, metformin, sitagliptin, GSK2330672, pharmacodynamic
Brief summary
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for 14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin 850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg, 20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID. Subjects will return for a follow-up visit 7-10 days after discharge.
Interventions
DRUGGSK2330672
GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed
DRUGPlacebo
Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed
DRUGSitagliptin
Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days
DRUGMetformin
Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 30 and 64 years of age inclusive, at the time of signing the informed consent * Subjects with a diagnosis of T2DM for at least 3 months prior to screening, taking metformin for at least 4 weeks prior to screening, taking a metformin daily dose of\>= 1000 mg and having an Glycosolated haemoglobin A1c (HbA1c) value of 7-11% inclusive at screening. The investigator should make an effort to obtain documentation of medical history or prescription of metformin to substantiate the diagnosis of T2DM * Fasting plasma glucose \<280 milligram per deciliter (mg/dl) at screening. A subject with a fasting plasma glucose at Day 1 that is more than 100 mg/dl lower than the screening value must not be randomized * All T2DM subjects must meet the label recommendations for metformin and sitagliptin, including: Adequate renal function, as evidenced by an estimated glomerular filtration rate \>= 80 milliliter per minute (mL/min) using the modification of diet in renal disease (MDRD) equation or chronic kidney disease epidemiology collaboration (CKD-EPI) formula in the study procedures manual (SPM); No conditions which make hypoxia, dehydration, or sepsis likely; No cardiac disease (including no history of myocardial infarction, stroke, hospitalization for acute coronary syndrome, or heart failure) * Body mass index (BMI) within the range 24 - 40 kilogram per meter square (kg/m\^2) (inclusive) * Other than T2DM, subjects should be in good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination that would introduce additional risk factors or interfere with study procedures or objectives, based on a medical evaluation including medical history, physical examination, vital signs, and laboratory tests * A female subject is eligible to participate if she is of non-childbearing potential defined as: Pre-menopausal females with a documented tubal ligation, bilateral oophorectomy, or hysterectomy \[for this definition, documented refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\]; OR Postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 million international units (MlU)/mL and estradiol \< 40 picogram (pg)/mL (\<147 picomol per liter) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods as described by the Investigator/designee, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method * Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods as described by the Investigator/designee. This criterion must be followed from the time of the first dose of study medication until the follow-up visit * Subjects must be willing to discontinue their usual dose of metformin and take the study dose of 850 mg immediate release formulation metformin BID for the 13-15 day run-in period and the 2-week treatment period * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion criteria
* The use of approved non-metformin anti-diabetic agents within 3 months of the screening visit * Hypoglycemia unawareness. T2DM subjects are excluded if, in the opinion of the investigator, they have significant hypoglycemia unawareness (for example, no symptoms of hypoglycemia when the blood glucose level is \<70 mg/dl) * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome). Subjects with a history of cholelithiasis, biliary colic, inflammatory gall bladder disease and/or cholestatic liver disease are excluded, unless this results in curative cholecystectomy 3 months or more before screening and with the approval of the GlaxoSmithKline (GSK) Medical Monitor * History of chronic or acute pancreatitis. Approval from the GSK Medical Monitor must be obtained for subjects with a past history of pancreatitis more than 12 months from the start of the Treatment Period (subjects with a history of pancreatitis within 12 months prior to the start of the Treatment Period are excluded). NOTE: Subjects with a lipase value above the upper limit of normal (ULN) at screening are excluded. A single repeat assessment is allowed within 3 days of the original test * History of Gastrointestinal (GI) disease (e.g., irritable bowel disease, chronic or current diarrhea, inflamed bowel, steatorrhoea/fat malabsorption, celiac disease, symptomatic lactose intolerance, small bowel resection). Subjects with gastroparesis requiring treatment are excluded. Subjects with history of prolapsed or bleeding haemorrhoids within 1 month of screening are excluded unless approved by the GSK Medical Monitor * History of autonomic neuropathy * History of epilepsy and/or use of anti-convulsants, including but not limited to phenobarbitone, phenytoin, carbamazepine, valproate * History of serious, severe, or unstable physical or psychiatric illness including depression, suicidal thoughts, schizophrenia, bipolar disorder, or generalized anxiety disorder. In addition to elicited symptoms and signs, this should include specific questions relating to known psychiatric diagnoses and medications used * History of significant cardiovascular disease not covered by the label recommendations for metformin, for example, ventricular tachyarrhythmias, peripheral arterial disease, and pulmonary embolism, within the previous 12 months * Uncontrolled hypertension, as evidenced by systolic pressure \>160 millimeters of mercury (mmHg) or diastolic pressure \>90 mmHg on a single assessment. If systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg, a single repeat is allowed within 1 hour. Subjects whose blood pressure is well-controlled by taking anti-hypertensive medications (e.g., beta blockers, angiotensin converting enzyme(ACE) inhibitors, angiotensin II receptor antagonists, calcium channel blockers, and thiazide diuretics) are permitted * History of untreated pernicious anemia or who have laboratory parameters suggestive of subclinical megaloblastic anemia (e.g., increased mean corpuscular volume \[MCV\] with low red blood cells \[RBC\] count and/or haemoglobin \[Hb\] level). * Thyroid disease: Uncorrected Thyroid Dysfunction as Fasting plasma thyroid stimulating hormone (TSH) outside of the normal range, as determined at the screening visit. Subjects on stable thyroid replacement therapy and with TSH in the normal range are eligible if approved by the GSK Medical Monitor. Unevaluated thyroid nodule or goiter at screening * History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits * History of sensitivity to heparin or heparin-induced thrombocytopenia * History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy (including other Dipeptidyl Peptidase-IV \[DPP-IV\] inhibitors) that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation * Current or relevant previous significant medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that, in the opinion of the investigator, presents undue risk from the study medication or procedures * Alanine aminotransferase (ALT)\>2xULN and bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * Fasting triglycerides \>= 400 mg/dl for subjects without a history of pancreatitis or \>250 mg/dl for subjects with a history of pancreatitis. Approval from the GSK Medical Monitor must be obtained for subjects with a past history of pancreatitis more than 12 months from the start of the treatment period (subjects with a history of pancreatitis within 12 months prior to the start of the treatment period are excluded). Subjects taking statins, ezetimibe, or Vytorin are permitted in the study. Subjects taking other lipid therapies, including but not limited to niacin, bile acid sequestrants and/or fibrates are not eligible * C-peptide of \<0.8 nanogram (ng)/mL at screening * Urine albumin-to-creatinine ratio \>0.3 mg albumin/mg creatinine * Positive fecal occult blood test at screening or during the run-in period * Significant ECG abnormalities, defined as follows: Heart Rate (resting) was \<50 and \>100 beats per minute (bpm); PR Interval between \<120 and \>220 millisecond (msec); QRS duration between \<70 and \>120 msec * Based on averaged QTcF of triplicate ECGs obtained at least 1 minute apart within approximately 15 minutes: QT duration corrected for heart rate by Fridericia's formula (QTcF) \>= 450 msec; OR QTcF \>= 480 msec in subjects with right Bundle Branch Block (subjects with left bundle branch block are excluded) * A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening * A positive test for HIV antibody * A positive urine drug screen or alcohol breath test at screening or during the run-in or treatment periods * A subject with a positive urine cotinine test result will be excluded from the study unless in the judgment of the investigator the subject will be able to abstain from using tobacco for the duration of the in-clinic treatment period of the study * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) * Exposure to more than four new chemical entities within 12 months prior to the first dosing day * Subjects who have participated in a previous study with GSK2330672 are excluded * Because of the potential impact on bile acid synthesis and secretion in the liver, use of rifampicin and/or other pregnane X receptor (PXR) inducers, including but not limited to St. John's Wort, is cause for subject exclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Up to Day 15 | Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15. |
| Summary of Urinalysis Data-mean pH | Baseline (pre-dose Day -1), Day 7 and 15 | Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Up to Day 15 | Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented. |
| Change From Baseline in Vital Signs Assessments-temperature | Baseline (pre-dose Day -1) and, Day 7, 15 | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. |
| Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (pre-dose Day -1) and Day 7, 15 | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. |
| Change From Baseline in Vital Signs Assessments-heart Rate | Baseline (pre-dose Day -1) and Day 7, 15 | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. |
| Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | Up to Day 15 (administered after every in-house bowel movement) | The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions. |
| Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | Up to Day 15 (administered after every in-house bowel movement) | The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions. |
| Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Day 7 and 14 | GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in \>=2 levels. |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours) | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment. |
| Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 14 days (treatment period) | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) \>= 3× upper limit of normal (ULN) and total bilirubin \>=2 × ULN (\>35% direct) or ALT \>=3 × ULN and international normalized ratio \>1.5. |
| Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | Up to Day 15 | Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. |
| Number of Participants With Abnormal Clinical Chemistry With PCI | Up to Day 15 | Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: \>=2×upper limit of normal \[ULN\]); AST (NR: 0-40; PCI: \>=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: \>=1.5× ULN). |
| Number of Participants With Abnormal Urinalysis Data | Baseline (pre-dose Day -1), Day 7 and 15 | Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, \>30, WBC: none seen, 0-5, 1, 2, 4, \<5, 6-10, 11-30, 19, \>30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality. |
| Summary of Urinalysis Data-mean Specific Gravity | Baseline (pre-dose Day -1), Day 7 and 15 | Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 | The time at which Cmax observed was determined directly from the raw concentration-time data. |
| PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 | PK population. Only those participants available at the specified time points were analyzed. |
| Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Baseline (pre-dose Day -1) and Day 7, 14 | Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs. |
| Ratio to Baseline in Fasting Apolipoprotein B | Baseline (pre-dose Day -1) and Day 7, 14 | Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs. |
| Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14 | The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2). |
| Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14 | The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin. |
| Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10) | Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14 | The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. |
| PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 | The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided. |
Countries
United States
Participant flow
Recruitment details
The study was conducted from 27 August 2014 to 30 January 2015. After interim analysis of safety, tolerability, pharmacodynamic and/or pharmacokinetic (PK) data, GSK2330672 10 and 20 milligram (mg) doses were dropped and GSK2330672 60 mg was added.
Pre-assignment details
A total of 187 participants were screened, of these, 112 were screen failures and 75 entered the run-in period. Five participants were withdrawn prior to taking a metformin dose in the 14 days of run-in period. A total of 64 participants were randomized to receive investigational product, as 6 participants were withdrawn prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were randomized to receive matching placebo solution of GSK2330672 orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The matching placebo solution of GSK2330672, was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 13 |
| GSK2330672 10 mg BID Participants were randomized to receive solution of GSK2330672 10 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 5 |
| GSK2330672 20 mg BID Participants were randomized to receive solution of GSK2330672 20 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued received metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 5 |
| GSK2330672 30 mg BID Participants were randomized to receive solution of GSK2330672 30 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 9 |
| GSK2330672 60 mg BID Participants were randomized to receive solution of GSK2330672 60 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 9 |
| GSK2330672 90 mg BID Participants were randomized to receive solution of GSK2330672 90 mg orally BID for 14 days. Participants drank the contents of dosing bottle (45 mL) followed by 2×50 mL rinses of bottle and then an additional 95 mL water for a total volume of 240 mL consumed. The solution of GSK2330672 (2 mg/mL), was prepared by clinical staff pharmacists after reconstitution of GSK2330672 powder with phosphate buffer into amber glass bottles for administration. All dosing treatments, bottle rinses and additional water was consumed within a 15 minute period. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the whole metformin tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 10 |
| Sitagliptin 50 mg BID Participants were randomized to receive sitagliptin 50 mg tablet orally BID for 14 days. Participants continued to receive metformin 850 mg tablet BID throughout the study (run-in and treatment period). Participants swallowed the both whole tablets of sitagliptin and metfornin with 240 mL of water each and were instructed to avoid chewing or crushing. | 13 |
| Run-in Only Participants were received open label metformin 850 mg tablet BID during run-in period, but were withdrawn prior to randomization. Participants swallowed the whole tablet with 240 mL of water and were instructed to avoid chewing or crushing. | 6 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Did not meet continuation criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Run-in Only | Sitagliptin 50 mg BID | GSK2330672 90 mg BID | GSK2330672 60 mg BID | GSK2330672 30 mg BID | GSK2330672 20 mg BID | GSK2330672 10 mg BID |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 52.1 Years STANDARD_DEVIATION 6.97 | 54.5 Years STANDARD_DEVIATION 6.2 | 55.5 Years STANDARD_DEVIATION 3.51 | 53.7 Years STANDARD_DEVIATION 6.79 | 54.8 Years STANDARD_DEVIATION 7.47 | 55.0 Years STANDARD_DEVIATION 4.27 | 57.1 Years STANDARD_DEVIATION 5.86 | 56.2 Years STANDARD_DEVIATION 8.5 | 54.0 Years STANDARD_DEVIATION 4.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 12 Participants | 1 Participants | 3 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 54 Participants | 5 Participants | 10 Participants | 9 Participants | 4 Participants | 8 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Female | 4 Participants | 31 Participants | 3 Participants | 5 Participants | 4 Participants | 6 Participants | 2 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 39 Participants | 3 Participants | 8 Participants | 6 Participants | 3 Participants | 7 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 5 | 0 / 5 | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 13 |
| other Total, other adverse events | 9 / 13 | 3 / 5 | 5 / 5 | 5 / 9 | 8 / 9 | 8 / 10 | 8 / 13 |
| serious Total, serious adverse events | 0 / 13 | 1 / 5 | 0 / 5 | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 13 |
Outcome results
Primary
Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour])
The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment.
Time frame: Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours)
Population: Safety population was used which was defined as all participants enrolled into the study who received at least one dose of study drug (including GSK2330672, GSK2330672-matched placebo, sitagliptin and metformin). Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 7 | -6.58 Mg/deciliter | Standard Deviation 16.357 |
| Placebo | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 14 | -10.00 Mg/deciliter | Standard Deviation 19.207 |
| Placebo | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 7 | 3.91 Mg/deciliter | Standard Deviation 20.668 |
| Placebo | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 14 | -9.94 Mg/deciliter | Standard Deviation 18.458 |
| GSK2330672 10 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 14 | -22.44 Mg/deciliter | Standard Deviation 15.928 |
| GSK2330672 10 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 7 | -12.14 Mg/deciliter | Standard Deviation 11.828 |
| GSK2330672 10 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 7 | -8.25 Mg/deciliter | Standard Deviation 6.5 |
| GSK2330672 10 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 14 | -22.75 Mg/deciliter | Standard Deviation 11.354 |
| GSK2330672 20 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 7 | -7.01 Mg/deciliter | Standard Deviation 17.262 |
| GSK2330672 20 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 14 | -16.20 Mg/deciliter | Standard Deviation 28.709 |
| GSK2330672 20 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 7 | -1.40 Mg/deciliter | Standard Deviation 23.05 |
| GSK2330672 20 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 14 | -17.80 Mg/deciliter | Standard Deviation 16.99 |
| GSK2330672 30 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 7 | -38.56 Mg/deciliter | Standard Deviation 24.744 |
| GSK2330672 30 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 14 | -48.67 Mg/deciliter | Standard Deviation 32.65 |
| GSK2330672 30 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 7 | -25.33 Mg/deciliter | Standard Deviation 25.819 |
| GSK2330672 30 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 14 | -37.48 Mg/deciliter | Standard Deviation 32.909 |
| GSK2330672 60 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 7 | -34.38 Mg/deciliter | Standard Deviation 19.398 |
| GSK2330672 60 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 14 | -32.22 Mg/deciliter | Standard Deviation 22.948 |
| GSK2330672 60 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 14 | -36.13 Mg/deciliter | Standard Deviation 23.117 |
| GSK2330672 60 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 7 | -21.47 Mg/deciliter | Standard Deviation 18.419 |
| GSK2330672 90 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 14 | -40.22 Mg/deciliter | Standard Deviation 19.156 |
| GSK2330672 90 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 7 | -24.78 Mg/deciliter | Standard Deviation 13.414 |
| GSK2330672 90 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 7 | -14.84 Mg/deciliter | Standard Deviation 18.569 |
| GSK2330672 90 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 14 | -45.54 Mg/deciliter | Standard Deviation 21.01 |
| Sitagliptin 50 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 7 | -26.63 Mg/deciliter | Standard Deviation 23.61 |
| Sitagliptin 50 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 7 | -24.54 Mg/deciliter | Standard Deviation 33.955 |
| Sitagliptin 50 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Fasting, Day 14 | -38.38 Mg/deciliter | Standard Deviation 16.439 |
| Sitagliptin 50 mg BID | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | WM AUC(0-24 hour), Day 14 | -35.85 Mg/deciliter | Standard Deviation 20.233 |
Comparison: An estimation approach was used.95% CI: [-42.56, -8.02]
Comparison: An estimation approach was used.95% CI: [-37.12, -2.82]
Comparison: An estimation approach was used.95% CI: [-25.61, 23.27]
Comparison: An estimation approach was used.95% CI: [-9.84, 36.27]
Comparison: An estimation approach was used.95% CI: [-41.43, -2.1]
Comparison: An estimation approach was used.95% CI: [-42.63, -3.57]
Comparison: An estimation approach was used.95% CI: [-30.85, 7.28]
Comparison: An estimation approach was used.95% CI: [-27.66, 7.57]
Comparison: An estimation approach was used.95% CI: [-37.72, 7.43]
Comparison: An estimation approach was used.95% CI: [-23.66, 19.45]
Comparison: An estimation approach was used.95% CI: [-38.75, -2.57]
Comparison: An estimation approach was used.95% CI: [-39.7, -3.71]
Comparison: An estimation approach was used.95% CI: [-28.62, 7.38]
Comparison: An estimation approach was used.95% CI: [-41.94, -10.12]
Comparison: An estimation approach was used.95% CI: [-33.56, 9.36]
Comparison: An estimation approach was used.95% CI: [-15.91, 24.57]
Comparison: An estimation approach was used.95% CI: [-38.56, -5.08]
Comparison: An estimation approach was used.95% CI: [-33.48, -2.55]
Comparison: An estimation approach was used.95% CI: [-33.21, 10.81]
Comparison: An estimation approach was used.95% CI: [-16.22, 25.81]
Comparison: An estimation approach was used.95% CI: [-32.86, 2.41]
Comparison: An estimation approach was used.95% CI: [-34.56, 0.53]
Comparison: An estimation approach was used.95% CI: [-41.49, -6.39]
Comparison: An estimation approach was used.95% CI: [-34.96, -3.93]
Primary
Change From Baseline in Vital Signs Assessments-heart Rate
The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.
Time frame: Baseline (pre-dose Day -1) and Day 7, 15
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs Assessments-heart Rate | Day 7 | -0.500 Beats per minute | Standard Deviation 8.1296 |
| Placebo | Change From Baseline in Vital Signs Assessments-heart Rate | Day 15 | 0.083 Beats per minute | Standard Deviation 3.1176 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 7 | 9.200 Beats per minute | Standard Deviation 8.228 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 15 | 0.250 Beats per minute | Standard Deviation 6.3443 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 7 | 4.400 Beats per minute | Standard Deviation 7.4027 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 15 | 9.200 Beats per minute | Standard Deviation 3.1937 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 7 | 0.556 Beats per minute | Standard Deviation 5.2941 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 15 | -0.444 Beats per minute | Standard Deviation 8.2932 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 7 | 4.667 Beats per minute | Standard Deviation 4.062 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 15 | 4.889 Beats per minute | Standard Deviation 7.4237 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 7 | 1.400 Beats per minute | Standard Deviation 7.0269 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 15 | 0.000 Beats per minute | Standard Deviation 8.8034 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 7 | -0.769 Beats per minute | Standard Deviation 6.2471 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-heart Rate | Day 15 | 1.846 Beats per minute | Standard Deviation 9.1364 |
Primary
Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.
Time frame: Baseline (pre-dose Day -1) and Day 7, 15
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | -0.083 Millimeters of mercury | Standard Deviation 6.8152 |
| Placebo | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 15 | 2.167 Millimeters of mercury | Standard Deviation 8.5049 |
| Placebo | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | 2.250 Millimeters of mercury | Standard Deviation 8.4544 |
| Placebo | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 15 | 0.750 Millimeters of mercury | Standard Deviation 6.107 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | -4.000 Millimeters of mercury | Standard Deviation 10.2225 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | -1.600 Millimeters of mercury | Standard Deviation 8.5323 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 15 | -2.750 Millimeters of mercury | Standard Deviation 4.5735 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 15 | -4.500 Millimeters of mercury | Standard Deviation 10.4722 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | -15.600 Millimeters of mercury | Standard Deviation 6.1482 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 15 | 1.800 Millimeters of mercury | Standard Deviation 5.8481 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | -6.600 Millimeters of mercury | Standard Deviation 1.9494 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 15 | 0.600 Millimeters of mercury | Standard Deviation 11.887 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 15 | -5.111 Millimeters of mercury | Standard Deviation 11.9105 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | -1.556 Millimeters of mercury | Standard Deviation 10.7948 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 15 | -1.333 Millimeters of mercury | Standard Deviation 9.1104 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | 2.222 Millimeters of mercury | Standard Deviation 17.6973 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | 1.222 Millimeters of mercury | Standard Deviation 9.1211 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | -4.111 Millimeters of mercury | Standard Deviation 4.9861 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 15 | -1.000 Millimeters of mercury | Standard Deviation 9.3541 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 15 | -1.667 Millimeters of mercury | Standard Deviation 3.937 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 15 | -2.667 Millimeters of mercury | Standard Deviation 6.3048 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | -4.300 Millimeters of mercury | Standard Deviation 10.9245 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | -2.700 Millimeters of mercury | Standard Deviation 6.7007 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 15 | -2.111 Millimeters of mercury | Standard Deviation 9.5321 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 15 | -4.385 Millimeters of mercury | Standard Deviation 9.2334 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | -2.462 Millimeters of mercury | Standard Deviation 7.677 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 15 | -0.769 Millimeters of mercury | Standard Deviation 5.0852 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | -5.462 Millimeters of mercury | Standard Deviation 10.3571 |
Primary
Change From Baseline in Vital Signs Assessments-temperature
The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.
Time frame: Baseline (pre-dose Day -1) and, Day 7, 15
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs Assessments-temperature | Day 7 | -0.133 Degree Celsius | Standard Deviation 0.257 |
| Placebo | Change From Baseline in Vital Signs Assessments-temperature | Day 15 | -0.208 Degree Celsius | Standard Deviation 0.337 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 15 | 0.025 Degree Celsius | Standard Deviation 0.1708 |
| GSK2330672 10 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 7 | -0.280 Degree Celsius | Standard Deviation 0.4764 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 7 | 0.040 Degree Celsius | Standard Deviation 0.4393 |
| GSK2330672 20 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 15 | -0.040 Degree Celsius | Standard Deviation 0.2966 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 15 | -0.111 Degree Celsius | Standard Deviation 0.5622 |
| GSK2330672 30 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 7 | 0.033 Degree Celsius | Standard Deviation 0.3937 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 15 | 0.056 Degree Celsius | Standard Deviation 0.2744 |
| GSK2330672 60 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 7 | 0.033 Degree Celsius | Standard Deviation 0.2062 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 15 | -0.178 Degree Celsius | Standard Deviation 0.5995 |
| GSK2330672 90 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 7 | 0.010 Degree Celsius | Standard Deviation 0.4458 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 15 | 0.062 Degree Celsius | Standard Deviation 0.3404 |
| Sitagliptin 50 mg BID | Change From Baseline in Vital Signs Assessments-temperature | Day 7 | 0.015 Degree Celsius | Standard Deviation 0.4451 |
Primary
Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14
The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.
Time frame: Up to Day 15 (administered after every in-house bowel movement)
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | 15.2 Count of bowel movements | Standard Deviation 9.29 |
| GSK2330672 10 mg BID | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | 28.2 Count of bowel movements | Standard Deviation 17.47 |
| GSK2330672 20 mg BID | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | 38.4 Count of bowel movements | Standard Deviation 10.74 |
| GSK2330672 30 mg BID | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | 35.0 Count of bowel movements | Standard Deviation 18.49 |
| GSK2330672 60 mg BID | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | 37.3 Count of bowel movements | Standard Deviation 30.72 |
| GSK2330672 90 mg BID | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | 35.9 Count of bowel movements | Standard Deviation 21.67 |
| Sitagliptin 50 mg BID | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | 15.0 Count of bowel movements | Standard Deviation 10.96 |
Primary
Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14
The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.
Time frame: Up to Day 15 (administered after every in-house bowel movement)
Population: Safety population. Only those participants available at the specified time points were analyzed. For each BSFS scale rating the Number of Participants Analyzed represents the number of participants reporting that rating not the number evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 7 events : Events | 16 Events |
| Placebo | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 6 events : Events | 59 Events |
| Placebo | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 3 events : Events | 28 Events |
| Placebo | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 5 events : Events | 30 Events |
| Placebo | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 2 events : Events | 6 Events |
| Placebo | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 4 events : Events | 56 Events |
| Placebo | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 1 event : Events | 2 Events |
| GSK2330672 10 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 6 events : Events | 81 Events |
| GSK2330672 10 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 7 events : Events | 51 Events |
| GSK2330672 10 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 4 events : Events | 7 Events |
| GSK2330672 10 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 5 events : Events | 2 Events |
| GSK2330672 20 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 2 events : Events | 2 Events |
| GSK2330672 20 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 5 events : Events | 8 Events |
| GSK2330672 20 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 7 events : Events | 47 Events |
| GSK2330672 20 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 3 events : Events | 4 Events |
| GSK2330672 20 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 6 events : Events | 113 Events |
| GSK2330672 20 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 4 events : Events | 18 Events |
| GSK2330672 30 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 1 event : Events | 1 Events |
| GSK2330672 30 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 2 events : Events | 1 Events |
| GSK2330672 30 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 3 events : Events | 1 Events |
| GSK2330672 30 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 4 events : Events | 19 Events |
| GSK2330672 30 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 5 events : Events | 26 Events |
| GSK2330672 30 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 6 events : Events | 181 Events |
| GSK2330672 30 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 7 events : Events | 86 Events |
| GSK2330672 60 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 5 events : Events | 9 Events |
| GSK2330672 60 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 6 events : Events | 250 Events |
| GSK2330672 60 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 4 events : Events | 21 Events |
| GSK2330672 60 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 7 events : Events | 50 Events |
| GSK2330672 60 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 3 events : Events | 6 Events |
| GSK2330672 90 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 5 events : Events | 30 Events |
| GSK2330672 90 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 4 events : Events | 24 Events |
| GSK2330672 90 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 3 events : Events | 5 Events |
| GSK2330672 90 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 7 events : Events | 98 Events |
| GSK2330672 90 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 1 event : Events | 1 Events |
| GSK2330672 90 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 6 events : Events | 201 Events |
| Sitagliptin 50 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 7 events : Events | 10 Events |
| Sitagliptin 50 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 5 events : Events | 26 Events |
| Sitagliptin 50 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 3 events : Events | 36 Events |
| Sitagliptin 50 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 2 events : Events | 10 Events |
| Sitagliptin 50 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 6 events : Events | 70 Events |
| Sitagliptin 50 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 1 event : Events | 2 Events |
| Sitagliptin 50 mg BID | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | BSFS scale rating, 4 events : Events | 41 Events |
Primary
Number of Participants With Abnormal Clinical Chemistry With PCI
Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: \>=2×upper limit of normal \[ULN\]); AST (NR: 0-40; PCI: \>=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: \>=1.5× ULN).
Time frame: Up to Day 15
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Clinical Chemistry With PCI | Total Bilirubin, hgh | 0 Participants |
| Placebo | Number of Participants With Abnormal Clinical Chemistry With PCI | AST, high | 0 Participants |
| Placebo | Number of Participants With Abnormal Clinical Chemistry With PCI | ALT, high | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | AST, high | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | ALT, high | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | Total Bilirubin, hgh | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | Total Bilirubin, hgh | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | ALT, high | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | AST, high | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | AST, high | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | ALT, high | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | Total Bilirubin, hgh | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | AST, high | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | ALT, high | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | Total Bilirubin, hgh | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | ALT, high | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | Total Bilirubin, hgh | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | AST, high | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | Total Bilirubin, hgh | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | AST, high | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Clinical Chemistry With PCI | ALT, high | 1 Participants |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline
Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented.
Time frame: Up to Day 15
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal clinically significant | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal not clinically significant | 4 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Normal | 9 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal not clinically significant | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Normal | 4 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal clinically significant | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal clinically significant | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Normal | 4 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal not clinically significant | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal not clinically significant | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Normal | 8 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal clinically significant | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal not clinically significant | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Normal | 6 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal clinically significant | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Normal | 6 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal clinically significant | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal not clinically significant | 4 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal clinically significant | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Abnormal not clinically significant | 4 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Normal | 9 Participants |
Primary
Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI)
Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided.
Time frame: Up to Day 15
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis Data
Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, \>30, WBC: none seen, 0-5, 1, 2, 4, \<5, 6-10, 11-30, 19, \>30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality.
Time frame: Baseline (pre-dose Day -1), Day 7 and 15
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 15, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, Trace | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Ketones, Day 7, Trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 0-5 | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 0-5 | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, none seen | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 4 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, small | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 3-10 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 0-2 | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 1 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, Trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, >30 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, Trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 0-2 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, 1+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace intact | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, none seen | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day -1, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 15, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 19 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 11-30 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, None seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, small | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 3-10 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, 1 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day -1, 1+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 11-30 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, 2+ | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, <5 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Casts, Day 7, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, Trace | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 1 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day -1, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 7, 2+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 0-5 | 1 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 7, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 2 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 11-30 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, Trace | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, >30 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 15, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day-1, 3+ | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 11-30 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day -1, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 6-10 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 7, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 1 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, small | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 4 | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 15, none seen | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, none seen | 2 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, >30 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 1 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, Trace | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 11-30 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 0-5 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 0-5 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 0-2 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, 2+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 1+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day -1, 1+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 4 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, 1+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, none seen | 2 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 15, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace intact | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 2+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Ketones, Day 7, Trace | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, <5 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, Trace | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 3-10 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, >30 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Casts, Day 7, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 3+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 2 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, Trace | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, >30 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 15, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 1 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, Trace | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, small | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 0-2 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, 1+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, Trace | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 11-30 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, small | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, none seen | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 7, 2+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 0-5 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day -1, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 19 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day-1, 3+ | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 11-30 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 1 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, None seen | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 6-10 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, small | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, 1+ | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 3-10 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 4 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, >30 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, 1 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, >30 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 0-2 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 15, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Ketones, Day 7, Trace | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, 1+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day -1, 1+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, Trace | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 7, 2+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace intact | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 1 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, small | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 0-5 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, 1+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, >30 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, Trace | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 19 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, small | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, small | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 11-30 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, 2+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, Trace | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, <5 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Casts, Day 7, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 11-30 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 1 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 0-5 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, 1 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 6-10 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day-1, 3+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 4 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 1 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, Trace | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 4 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 0-5 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 1+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 2+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 3-10 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 3+ | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 15, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, Trace | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 0-2 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, 1+ | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day -1, none seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, >30 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, None seen | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 2 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 3-10 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 7, 2+ | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, Trace | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, small | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day-1, 3+ | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace intact | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, small | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, 1+ | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, Trace | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, small | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, 2+ | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Casts, Day 7, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, Trace | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 1+ | 3 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 2+ | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 3+ | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, Trace | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, 1+ | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day -1, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, None seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, 1 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 15, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Ketones, Day 7, Trace | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day -1, 1+ | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, Trace | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, 1+ | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, none seen | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 0-2 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 3-10 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, none seen | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 0-2 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 15, none seen | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 3-10 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, none seen | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 0-5 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 1 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 4 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 6-10 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, >30 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 0-5 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 1 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, <5 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 11-30 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 19 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, >30 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 0-5 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 1 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 2 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 4 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 11-30 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, >30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, >30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, None seen | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 3-10 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day -1, none seen | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 2 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, 1+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, none seen | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, Trace | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 0-2 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 3+ | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 15, none seen | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 2+ | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 3-10 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 1+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day-1, 3+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, none seen | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, Trace | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, >30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 0-5 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 15, none seen | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 4 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 1 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 7, none seen | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 4 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day -1, none seen | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 6-10 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 15, none seen | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 7, none seen | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, >30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day -1, none seen | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, small | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 0-5 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Casts, Day 7, none seen | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 1 | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, 2+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 11-30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, <5 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, small | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 11-30 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, Trace | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 19 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, 1+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, small | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 0-5 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace intact | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, Trace | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 1 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 7, 2+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day -1, 1+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, Trace | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Ketones, Day 7, Trace | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, 1+ | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 15, none seen | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, none seen | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, 1 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 0-2 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, Trace | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, 1+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 0-5 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 1 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 7, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 4 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 4 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace intact | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 6-10 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 15, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 15, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 1 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, small | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, >30 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day -1, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 7, 2+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 0-5 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Casts, Day 7, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day -1, 1+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, >30 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 1 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, 2+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, 1 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, Trace | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, <5 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, small | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 11-30 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, None seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 11-30 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 3-10 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day -1, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, Trace | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Ketones, Day 7, Trace | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 11-30 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, 1+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 2 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, Trace | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 19 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 0-2 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 3+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, 1+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 15, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 2+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day-1, 3+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 3-10 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 1+ | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 0-2 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, >30 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, none seen | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, Trace | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, small | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 0-5 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Ketones, Day 7, Trace | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 0-2 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, None seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, 1+ | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day-1, 3+ | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 1 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 7, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, >30 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 0-5 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 11-30 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace intact | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 0-5 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 4 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day -1, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 3-10 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day -1, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 4 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, 1+ | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, >30 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 6-10 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 15, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, Trace | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 15, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, small | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 15, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 2+ | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, 11-30 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day 7, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day -1, 11-30 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, 1+ | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Hyaline Casts, Day 7, 1 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, Trace | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, >30 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Cellular Casts, Day -1, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 11-30 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day -1, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 7, 2+ | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day -1, 1+ | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day -1, Trace | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 0-5 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Casts, Day 7, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, Trace | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, none seen | 2 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day 7, Trace | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 3-10 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 1+ | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 1 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, 2+ | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 2 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 15, 1 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, 19 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-Granular Casts, Day 15, none seen | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-RBC, Day 7, 0-2 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Microscopy-WBC, Day 7, <5 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 15, small | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Glucose, Day -1, 3+ | 2 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Protein, Day 15, Trace | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Abnormal Urinalysis Data | Urine Occult Blood, Day 7, small | 0 Participants |
Primary
Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding
Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15.
Time frame: Up to Day 15
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 0 Participants |
| Placebo | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 1 Participants |
| Run-in Only | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal not clinically significant | 0 Participants |
| Run-in Only | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Abnormal clinically significant | 2 Participants |
Primary
Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels)
GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in \>=2 levels.
Time frame: Day 7 and 14
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensatn not complete empty bowels, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 7 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 7 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 7 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 14 | 2 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensation not complete empty bowels, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 7 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 7 | 2 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 7 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 7 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 14 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 14 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 7 | 0 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 7 | 1 Participants |
| Placebo | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 7 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensatn not complete empty bowels, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensation not complete empty bowels, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 7 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 14 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 14 | 1 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 7 | 0 Participants |
| GSK2330672 10 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 7 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 7 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 7 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 7 | 3 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 7 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 7 | 3 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 7 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 7 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensatn not complete empty bowels, Day 7 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 7 | 0 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 7 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 7 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 14 | 4 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 14 | 3 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 14 | 4 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensation not complete empty bowels, Day 14 | 3 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 14 | 2 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 14 | 3 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 14 | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 7 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 7 | 3 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 14 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 7 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 14 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 14 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 7 | 4 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 14 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 7 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 14 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 7 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensation not complete empty bowels, Day 14 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 7 | 4 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 14 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensatn not complete empty bowels, Day 7 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 14 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 7 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 14 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 14 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 14 | 2 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 7 | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 14 | 3 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 14 | 1 Participants |
| GSK2330672 30 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 7 | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 7 | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 7 | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 14 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 7 | 4 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 14 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 7 | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 14 | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 14 | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 7 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 14 | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensation not complete empty bowels, Day 14 | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 7 | 1 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensatn not complete empty bowels, Day 7 | 3 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 7 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 7 | 2 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 14 | 0 Participants |
| GSK2330672 60 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 7 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensatn not complete empty bowels, Day 7 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 7 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 14 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 7 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 14 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 7 | 4 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 7 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 7 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 7 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 7 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 14 | 5 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 14 | 3 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 14 | 3 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 7 | 3 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 7 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 7 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 14 | 3 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 7 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 7 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensation not complete empty bowels, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 14 | 3 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 7 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 7 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 7 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 14 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 7 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 14 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 7 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 7 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 7 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 14 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 14 | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 14 | 2 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 14 | 1 Participants |
| GSK2330672 90 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 7 | 3 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hard stools, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 7 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensation not complete empty bowels, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Urgent need to have bowel movement, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Hunger pains, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 14 | 1 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation syndrome, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Reflux syndrome, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Loose stools, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Indigestion syndrome, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Overall GSRS, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Diarrhea syndrome, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Rumbling, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Sensatn not complete empty bowels, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 14 | 00 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Acid reflux, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Burping, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Heartburn, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Nausea, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Passing gas or flatus, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Pain/discomfort in upper abdomen, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Abdominal pain, Day 7 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Constipation, Day 14 | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Bloated, Day 7 | 0 Participants |
Primary
Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) \>= 3× upper limit of normal (ULN) and total bilirubin \>=2 × ULN (\>35% direct) or ALT \>=3 × ULN and international normalized ratio \>1.5.
Time frame: Up to 14 days (treatment period)
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| Placebo | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 9 Participants |
| GSK2330672 10 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 4 Participants |
| GSK2330672 10 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 1 Participants |
| GSK2330672 20 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 5 Participants |
| GSK2330672 20 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| GSK2330672 30 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 5 Participants |
| GSK2330672 60 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 8 Participants |
| GSK2330672 60 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| GSK2330672 90 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 8 Participants |
| GSK2330672 90 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 0 Participants |
| Sitagliptin 50 mg BID | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 8 Participants |
Primary
Summary of Urinalysis Data-mean pH
Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Baseline (pre-dose Day -1), Day 7 and 15
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Summary of Urinalysis Data-mean pH | Day 7 | 5.83 Unit on a scale | Standard Deviation 0.389 |
| Placebo | Summary of Urinalysis Data-mean pH | Day -1 | 5.73 Unit on a scale | Standard Deviation 0.388 |
| Placebo | Summary of Urinalysis Data-mean pH | Day 15 | 5.88 Unit on a scale | Standard Deviation 0.377 |
| GSK2330672 10 mg BID | Summary of Urinalysis Data-mean pH | Day 15 | 5.88 Unit on a scale | Standard Deviation 0.25 |
| GSK2330672 10 mg BID | Summary of Urinalysis Data-mean pH | Day -1 | 6.00 Unit on a scale | Standard Deviation 0 |
| GSK2330672 10 mg BID | Summary of Urinalysis Data-mean pH | Day 7 | 5.90 Unit on a scale | Standard Deviation 0.224 |
| GSK2330672 20 mg BID | Summary of Urinalysis Data-mean pH | Day 15 | 6.00 Unit on a scale | Standard Deviation 0 |
| GSK2330672 20 mg BID | Summary of Urinalysis Data-mean pH | Day 7 | 6.00 Unit on a scale | Standard Deviation 0 |
| GSK2330672 20 mg BID | Summary of Urinalysis Data-mean pH | Day -1 | 6.10 Unit on a scale | Standard Deviation 0.224 |
| GSK2330672 30 mg BID | Summary of Urinalysis Data-mean pH | Day -1 | 6.11 Unit on a scale | Standard Deviation 0.22 |
| GSK2330672 30 mg BID | Summary of Urinalysis Data-mean pH | Day 7 | 5.89 Unit on a scale | Standard Deviation 0.22 |
| GSK2330672 30 mg BID | Summary of Urinalysis Data-mean pH | Day 15 | 6.00 Unit on a scale | Standard Deviation 0 |
| GSK2330672 60 mg BID | Summary of Urinalysis Data-mean pH | Day 7 | 5.61 Unit on a scale | Standard Deviation 0.486 |
| GSK2330672 60 mg BID | Summary of Urinalysis Data-mean pH | Day 15 | 5.72 Unit on a scale | Standard Deviation 0.565 |
| GSK2330672 60 mg BID | Summary of Urinalysis Data-mean pH | Day -1 | 5.83 Unit on a scale | Standard Deviation 0.354 |
| GSK2330672 90 mg BID | Summary of Urinalysis Data-mean pH | Day 7 | 5.95 Unit on a scale | Standard Deviation 0.284 |
| GSK2330672 90 mg BID | Summary of Urinalysis Data-mean pH | Day -1 | 5.95 Unit on a scale | Standard Deviation 0.438 |
| GSK2330672 90 mg BID | Summary of Urinalysis Data-mean pH | Day 15 | 6.06 Unit on a scale | Standard Deviation 0.167 |
| Sitagliptin 50 mg BID | Summary of Urinalysis Data-mean pH | Day -1 | 5.85 Unit on a scale | Standard Deviation 0.516 |
| Sitagliptin 50 mg BID | Summary of Urinalysis Data-mean pH | Day 15 | 5.88 Unit on a scale | Standard Deviation 0.416 |
| Sitagliptin 50 mg BID | Summary of Urinalysis Data-mean pH | Day 7 | 5.69 Unit on a scale | Standard Deviation 0.435 |
Primary
Summary of Urinalysis Data-mean Specific Gravity
Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
Time frame: Baseline (pre-dose Day -1), Day 7 and 15
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Summary of Urinalysis Data-mean Specific Gravity | Day 7 | 1.0196 Ratio | Standard Deviation 0.00753 |
| Placebo | Summary of Urinalysis Data-mean Specific Gravity | Day -1 | 1.0193 Ratio | Standard Deviation 0.00694 |
| Placebo | Summary of Urinalysis Data-mean Specific Gravity | Day 15 | 1.0188 Ratio | Standard Deviation 0.00403 |
| GSK2330672 10 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 7 | 1.0208 Ratio | Standard Deviation 0.00904 |
| GSK2330672 10 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day -1 | 1.0182 Ratio | Standard Deviation 0.00581 |
| GSK2330672 10 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 15 | 1.0193 Ratio | Standard Deviation 0.00435 |
| GSK2330672 20 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 7 | 1.0184 Ratio | Standard Deviation 0.00896 |
| GSK2330672 20 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day -1 | 1.0128 Ratio | Standard Deviation 0.00421 |
| GSK2330672 20 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 15 | 1.0158 Ratio | Standard Deviation 0.00259 |
| GSK2330672 30 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day -1 | 1.0190 Ratio | Standard Deviation 0.00618 |
| GSK2330672 30 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 15 | 1.0132 Ratio | Standard Deviation 0.00471 |
| GSK2330672 30 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 7 | 1.0191 Ratio | Standard Deviation 0.00739 |
| GSK2330672 60 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 7 | 1.0194 Ratio | Standard Deviation 0.00726 |
| GSK2330672 60 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day -1 | 1.0172 Ratio | Standard Deviation 0.0061 |
| GSK2330672 60 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 15 | 1.0121 Ratio | Standard Deviation 0.00348 |
| GSK2330672 90 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day -1 | 1.0189 Ratio | Standard Deviation 0.0078 |
| GSK2330672 90 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 7 | 1.0208 Ratio | Standard Deviation 0.00859 |
| GSK2330672 90 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 15 | 1.0160 Ratio | Standard Deviation 0.00787 |
| Sitagliptin 50 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 7 | 1.0160 Ratio | Standard Deviation 0.0079 |
| Sitagliptin 50 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day -1 | 1.0148 Ratio | Standard Deviation 0.00706 |
| Sitagliptin 50 mg BID | Summary of Urinalysis Data-mean Specific Gravity | Day 15 | 1.0140 Ratio | Standard Deviation 0.00815 |
Secondary
PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10])
PK population. Only those participants available at the specified time points were analyzed.
Time frame: Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14
Population: PK population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | 6805.8 Hour×ng/mL | Geometric Coefficient of Variation 19.7 |
| GSK2330672 10 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | 5982.0 Hour×ng/mL | Geometric Coefficient of Variation 34.72 |
| GSK2330672 20 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | 7066.2 Hour×ng/mL | Geometric Coefficient of Variation 25.8 |
| GSK2330672 30 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | 7066.5 Hour×ng/mL | Geometric Coefficient of Variation 16.09 |
| GSK2330672 60 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | 8090.5 Hour×ng/mL | Geometric Coefficient of Variation 33.06 |
| GSK2330672 90 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | 8375.3 Hour×ng/mL | Geometric Coefficient of Variation 32.78 |
| Sitagliptin 50 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | 8425.4 Hour×ng/mL | Geometric Coefficient of Variation 28.11 |
90% CI: [0.68, 1.13]
90% CI: [0.82, 1.31]
90% CI: [0.85, 1.26]
90% CI: [0.97, 1.45]
90% CI: [1.01, 1.49]
90% CI: [1.04, 1.48]
Secondary
PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax)
The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided.
Time frame: Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14
Population: The PK population was used which was defined as participants from the safety population who had plasma metformin, sitagliptin, and/or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | 1102.2 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 26.92 |
| GSK2330672 10 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | 1289.3 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 41.81 |
| GSK2330672 20 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | 1219.9 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 23.76 |
| GSK2330672 30 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | 1160.0 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 18.64 |
| GSK2330672 60 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | 1378.8 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 22.77 |
| GSK2330672 90 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | 1376.6 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 21.7 |
| Sitagliptin 50 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | 1223.5 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 27.36 |
90% CI: [0.92, 1.49]
90% CI: [0.89, 1.38]
90% CI: [0.87, 1.27]
90% CI: [1.03, 1.52]
90% CI: [1.04, 1.5]
90% CI: [0.94, 1.31]
Secondary
PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax)
The time at which Cmax observed was determined directly from the raw concentration-time data.
Time frame: Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14
Population: PK population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | 1.510 Hour |
| GSK2330672 10 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | 1.000 Hour |
| GSK2330672 20 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | 1.000 Hour |
| GSK2330672 30 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | 1.050 Hour |
| GSK2330672 60 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | 1.750 Hour |
| GSK2330672 90 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | 1.500 Hour |
| Sitagliptin 50 mg BID | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | 2.050 Hour |
Secondary
Ratio to Baseline in Fasting Apolipoprotein B
Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.
Time frame: Baseline (pre-dose Day -1) and Day 7, 14
Population: Safety population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Ratio to Baseline in Fasting Apolipoprotein B | Day 7 | 0.97 Ratio | Geometric Coefficient of Variation 10.6 |
| Placebo | Ratio to Baseline in Fasting Apolipoprotein B | Day 14 | 0.93 Ratio | Geometric Coefficient of Variation 14.2 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 7 | 0.95 Ratio | Geometric Coefficient of Variation 5.9 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 14 | 0.85 Ratio | Geometric Coefficient of Variation 6.7 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 7 | 0.78 Ratio | Geometric Coefficient of Variation 13.9 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 14 | 0.75 Ratio | Geometric Coefficient of Variation 19 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 7 | 0.81 Ratio | Geometric Coefficient of Variation 13.1 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 14 | 0.78 Ratio | Geometric Coefficient of Variation 19.6 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 7 | 0.69 Ratio | Geometric Coefficient of Variation 12 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 14 | 0.67 Ratio | Geometric Coefficient of Variation 14.9 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 7 | 0.76 Ratio | Geometric Coefficient of Variation 3.8 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 14 | 0.69 Ratio | Geometric Coefficient of Variation 9.3 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 7 | 0.96 Ratio | Geometric Coefficient of Variation 10.3 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Apolipoprotein B | Day 14 | 0.88 Ratio | Geometric Coefficient of Variation 15.5 |
Comparison: An estimation approach was used.95% CI: [0.87, 1.11]
Comparison: An estimation approach was used.95% CI: [0.71, 0.89]
Comparison: An estimation approach was used.95% CI: [0.74, 0.9]
Comparison: An estimation approach was used.95% CI: [0.63, 0.77]
Comparison: An estimation approach was used.95% CI: [0.7, 0.85]
Comparison: An estimation approach was used.95% CI: [0.89, 1.06]
Comparison: An estimation approach was used.95% CI: [0.77, 1.07]
Comparison: An estimation approach was used.95% CI: [0.68, 0.95]
Comparison: An estimation approach was used.95% CI: [0.7, 0.91]
Comparison: An estimation approach was used.95% CI: [0.58, 0.77]
Comparison: An estimation approach was used.95% CI: [0.64, 0.83]
Comparison: An estimation approach was used.95% CI: [0.8, 1.02]
Secondary
Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides
Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.
Time frame: Baseline (pre-dose Day -1) and Day 7, 14
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 14 | 0.99 Ratio | Geometric Coefficient of Variation 6.5 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 7 | 1.00 Ratio | Geometric Coefficient of Variation 7.3 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 14 | 0.85 Ratio | Geometric Coefficient of Variation 23 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 7 | 0.85 Ratio | Geometric Coefficient of Variation 20.6 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 14 | 0.94 Ratio | Geometric Coefficient of Variation 17.7 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 7 | 0.93 Ratio | Geometric Coefficient of Variation 13.8 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 14 | 0.94 Ratio | Geometric Coefficient of Variation 17.6 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 14 | 0.95 Ratio | Geometric Coefficient of Variation 13.1 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 7 | 0.95 Ratio | Geometric Coefficient of Variation 10.9 |
| Placebo | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 7 | 0.97 Ratio | Geometric Coefficient of Variation 14.6 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 14 | 0.98 Ratio | Geometric Coefficient of Variation 14.2 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 7 | 0.99 Ratio | Geometric Coefficient of Variation 12.1 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 7 | 1.08 Ratio | Geometric Coefficient of Variation 12.8 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 14 | 1.11 Ratio | Geometric Coefficient of Variation 1.5 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 7 | 0.89 Ratio | Geometric Coefficient of Variation 6.4 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 14 | 0.80 Ratio | Geometric Coefficient of Variation 4.2 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 7 | 0.96 Ratio | Geometric Coefficient of Variation 12.6 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 14 | 0.94 Ratio | Geometric Coefficient of Variation 17.5 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 7 | 1.07 Ratio | Geometric Coefficient of Variation 51.2 |
| GSK2330672 10 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 14 | 1.21 Ratio | Geometric Coefficient of Variation 63.3 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 7 | 0.93 Ratio | Geometric Coefficient of Variation 18.8 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 7 | 0.78 Ratio | Geometric Coefficient of Variation 18.2 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 14 | 0.81 Ratio | Geometric Coefficient of Variation 20.8 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 7 | 0.77 Ratio | Geometric Coefficient of Variation 21.1 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 14 | 0.74 Ratio | Geometric Coefficient of Variation 29.7 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 7 | 0.84 Ratio | Geometric Coefficient of Variation 12.4 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 7 | 1.05 Ratio | Geometric Coefficient of Variation 8.9 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 14 | 0.96 Ratio | Geometric Coefficient of Variation 35.8 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 14 | 0.69 Ratio | Geometric Coefficient of Variation 23.1 |
| GSK2330672 20 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 14 | 1.02 Ratio | Geometric Coefficient of Variation 4 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 14 | 0.83 Ratio | Geometric Coefficient of Variation 18.5 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 7 | 0.84 Ratio | Geometric Coefficient of Variation 13.7 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 14 | 0.97 Ratio | Geometric Coefficient of Variation 8.8 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 14 | 1.07 Ratio | Geometric Coefficient of Variation 34.3 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 7 | 0.73 Ratio | Geometric Coefficient of Variation 21.5 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 7 | 0.80 Ratio | Geometric Coefficient of Variation 18.2 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 14 | 0.78 Ratio | Geometric Coefficient of Variation 23.7 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 14 | 0.72 Ratio | Geometric Coefficient of Variation 23.7 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 7 | 1.11 Ratio | Geometric Coefficient of Variation 24.5 |
| GSK2330672 30 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 7 | 0.97 Ratio | Geometric Coefficient of Variation 8 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 7 | 0.74 Ratio | Geometric Coefficient of Variation 11 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 14 | 0.67 Ratio | Geometric Coefficient of Variation 7.2 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 7 | 0.95 Ratio | Geometric Coefficient of Variation 11.4 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 7 | 0.58 Ratio | Geometric Coefficient of Variation 21.2 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 14 | 0.75 Ratio | Geometric Coefficient of Variation 8.8 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 14 | 0.60 Ratio | Geometric Coefficient of Variation 15 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 7 | 0.98 Ratio | Geometric Coefficient of Variation 19.8 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 7 | 0.65 Ratio | Geometric Coefficient of Variation 12 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 14 | 0.96 Ratio | Geometric Coefficient of Variation 11.4 |
| GSK2330672 60 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 14 | 1.00 Ratio | Geometric Coefficient of Variation 16.6 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 14 | 1.00 Ratio | Geometric Coefficient of Variation 23.7 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 14 | 1.01 Ratio | Geometric Coefficient of Variation 11.6 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 7 | 0.71 Ratio | Geometric Coefficient of Variation 6.5 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 14 | 0.67 Ratio | Geometric Coefficient of Variation 16.3 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 7 | 0.80 Ratio | Geometric Coefficient of Variation 3.7 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 7 | 0.73 Ratio | Geometric Coefficient of Variation 5.1 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 14 | 0.68 Ratio | Geometric Coefficient of Variation 8.6 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 7 | 0.93 Ratio | Geometric Coefficient of Variation 16.3 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 14 | 0.75 Ratio | Geometric Coefficient of Variation 6.7 |
| GSK2330672 90 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 7 | 1.09 Ratio | Geometric Coefficient of Variation 15.7 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 14 | 0.92 Ratio | Geometric Coefficient of Variation 15.3 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 14 | 0.74 Ratio | Geometric Coefficient of Variation 34.5 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 14 | 0.97 Ratio | Geometric Coefficient of Variation 10.2 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 14 | 0.92 Ratio | Geometric Coefficient of Variation 11.1 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Cholesterol, Day 7 | 0.97 Ratio | Geometric Coefficient of Variation 9.8 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Triglycerides, Day 7 | 0.79 Ratio | Geometric Coefficient of Variation 32.7 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | LDL cholesterol, Day 7 | 1.00 Ratio | Geometric Coefficient of Variation 10.5 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | HDL cholesterol, Day 7 | 0.97 Ratio | Geometric Coefficient of Variation 9 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 14 | 0.90 Ratio | Geometric Coefficient of Variation 15.1 |
| Sitagliptin 50 mg BID | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Non-HDL Cholesterol, Day 7 | 0.98 Ratio | Geometric Coefficient of Variation 11.9 |
Comparison: An estimation approach was used.95% CI: [0.91, 1.17]
Comparison: An estimation approach was used.95% CI: [0.78, 0.98]
Comparison: An estimation approach was used.95% CI: [0.78, 0.95]
Comparison: An estimation approach was used.95% CI: [0.68, 0.83]
Comparison: An estimation approach was used.95% CI: [0.76, 0.92]
Comparison: An estimation approach was used.95% CI: [0.92, 1.1]
Comparison: An estimation approach was used.95% CI: [0.95, 1.19]
Comparison: An estimation approach was used.95% CI: [0.94, 1.16]
Comparison: An estimation approach was used.95% CI: [0.88, 1.05]
Comparison: An estimation approach was used.95% CI: [0.89, 1.07]
Comparison: An estimation approach was used.95% CI: [0.98, 1.17]
Comparison: An estimation approach was used.95% CI: [0.9, 1.05]
Comparison: An estimation approach was used.95% CI: [0.8, 1.13]
Comparison: An estimation approach was used.95% CI: [0.65, 0.9]
Comparison: An estimation approach was used.95% CI: [0.64, 0.85]
Comparison: An estimation approach was used.95% CI: [0.51, 0.69]
Comparison: An estimation approach was used.95% CI: [0.62, 0.81]
Comparison: An estimation approach was used.95% CI: [0.89, 1.14]
Comparison: An estimation approach was used.95% CI: [0.88, 1.21]
Comparison: An estimation approach was used.95% CI: [0.71, 0.95]
Comparison: An estimation approach was used.95% CI: [0.74, 0.95]
Comparison: An estimation approach was used.95% CI: [0.59, 0.76]
Comparison: An estimation approach was used.95% CI: [0.68, 0.87]
Comparison: An estimation approach was used.95% CI: [0.92, 1.14]
Comparison: An estimation approach was used.95% CI: [0.97, 1.66]
Comparison: An estimation approach was used.95% CI: [0.9, 1.5]
Comparison: An estimation approach was used.95% CI: [1.06, 1.61]
Comparison: An estimation approach was used.95% CI: [0.96, 1.48]
Comparison: An estimation approach was used.95% CI: [0.93, 1.42]
Comparison: An estimation approach was used.95% CI: [0.79, 1.16]
Comparison: An estimation approach was used.95% CI: [0.86, 1.17]
Comparison: An estimation approach was used.95% CI: [0.73, 0.96]
Comparison: An estimation approach was used.95% CI: [0.73, 0.91]
Comparison: An estimation approach was used.95% CI: [0.66, 0.82]
Comparison: An estimation approach was used.95% CI: [0.69, 0.86]
Comparison: An estimation approach was used.95% CI: [0.84, 1.03]
Comparison: An estimation approach was used.95% CI: [0.99, 1.21]
Comparison: An estimation approach was used.95% CI: [0.93, 1.11]
Comparison: An estimation approach was used.95% CI: [0.9, 1.04]
Comparison: An estimation approach was used.95% CI: [0.92, 1.06]
Comparison: An estimation approach was used.95% CI: [0.94, 1.08]
Comparison: An estimation approach was used.95% CI: [0.92, 1.04]
Comparison: An estimation approach was used.95% CI: [0.69, 1.04]
Comparison: An estimation approach was used.95% CI: [0.58, 0.85]
Comparison: An estimation approach was used.95% CI: [0.62, 0.86]
Comparison: An estimation approach was used.95% CI: [0.5, 0.71]
Comparison: An estimation approach was used.95% CI: [0.59, 0.8]
Comparison: An estimation approach was used.95% CI: [0.81, 1.09]
Comparison: An estimation approach was used.95% CI: [0.8, 1.22]
Comparison: An estimation approach was used.95% CI: [0.64, 0.93]
Comparison: An estimation approach was used.95% CI: [0.67, 0.9]
Comparison: An estimation approach was used.95% CI: [0.55, 0.75]
Comparison: An estimation approach was used.95% CI: [0.6, 0.81]
Comparison: An estimation approach was used.95% CI: [0.8, 1.04]
Comparison: An estimation approach was used.95% CI: [1.01, 2]
Comparison: An estimation approach was used.95% CI: [0.94, 1.75]
Comparison: An estimation approach was used.95% CI: [0.98, 1.58]
Comparison: An estimation approach was used.95% CI: [0.95, 1.56]
Comparison: An estimation approach was used.95% CI: [0.96, 1.57]
Comparison: An estimation approach was used.95% CI: [0.72, 1.11]
Secondary
Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10)
The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Time frame: Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14
Population: PK population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10) | 1473.5 Hour×ng/mL | Geometric Coefficient of Variation 22.45 |
Secondary
Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses
The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2).
Time frame: Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14
Population: PK population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses | Cmax 1 | 238.2 Ng/mL | Geometric Coefficient of Variation 26.2 |
| Placebo | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses | Cmax 2 | 188.5 Ng/mL | Geometric Coefficient of Variation 25.34 |
Secondary
Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses
The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin.
Time frame: Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14
Population: PK population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses | Tmax 1 | 2.000 Hour |
| Placebo | Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses | Tmax 2 | 3.050 Hour |