Diabetes Mellitus, Type 2
Conditions
Keywords
Safety, Dose Ranging, Efficacy
Brief summary
The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.
Detailed description
The study will be conducted at centers in Europe and the United States. The study is being conducted in two parts. Part A (n = 90 subjects) will provide a preliminary evaluation of 12 weeks of treatment. Initiation of part B (n = 210 additional subjects) will be dependent on the results observed in part A. The emerging data from part A will be used to guide selection of the doses in Part B. Up to 8 dose levels of GSK256073 may be included in part B. The emerging exposure response relationships from the part A interim analysis will be used to guide dose selection. Each subject enrolled in the study will undergo screening procedures, a 2 week placebo run-in period, baseline assessments, randomization, a twelve week treatment period, and a 2 week follow-up period. Following completion of the baseline visit and randomization into the study, subjects will return to the clinic for safety and efficacy assessments at Weeks 3, 6, 9, and 12. A subject's total participation in the study will last up to approximately 20 weeks. Subjects will continue their current prescribed regimen of metformin (glucophage) monotherapy and will monitor fasting blood glucose levels daily using a glucometer.
Interventions
DRUGGSK256073 1mg
GSK256073 1mg capsule
DRUGGSK256073 5mg
GSK256073 5mg capsule
DRUGGSK256073 10mg
GSK256073 10mg capsule
DRUGGSK256073 25mg
GSK256073 25mg capsule
DRUGPlacebo
placebo capsule
Sitagliptin 100mg capsule
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests, with onset at least 6 months prior to Screening. Subjects may be entered if they have stable hypertension or dyslipidemia on therapy. Subjects with other conditions except as noted in the
Exclusion criteria
may be included only if the investigator and GSK medical monitor agree that the condition is unlikely to introduce additional risk factors and will not interfere with study procedures * HbA1c levels greater than or equal to 7.0 % and less than or equal to 9.5% at Screening * On monotherapy with metformin at the time of screening, and at a maximum tolerated dose greater than or equal to 1000 mg for at least 2 months prior to dosing. * Fasting plasma glucose level less than 13.3 mmol/L (240 mg/dL) at Screening * Male or female between 20 and 70 years of age, inclusive, at the time of signing the informed consent * Fasting Triglycerides lower than 4.52 mmol/L (400 mg/dL) * A female subject is able to participate is she if of non-child bearing potential * Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 3 days after last dose of the study medication * Overweight with BMI greater than or equal to 25 kg/m2 for non-Asian Indians and greater than or equal to 24 kg/m2 for Asian-Indian, and less than 40 kg/m2 * The subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form * Subjects in France will be eligible only if they are affiliated to or a beneficiary of a social security category * Subjects in other countries must meet all local and/or country-specific requirements for registration and reimbursement, as applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Baseline (Day -1) and up to Week 12 | Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Week 12 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (pre-dose Day 1) and up to Week 12 | Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12. |
| Change From Baseline in Heart Rate | Baseline (pre-dose Day 1) and up to Week 12 | Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12. |
| Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Up to Week 20 | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented. |
| Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Up to Week 12 | 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, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12. Data for parameters with high and low of PCI is provided. |
| Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Up to Week 12 | 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, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided. |
| Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Up to Week 12 | Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship | Up to Week 12 | The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected. |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Baseline (Day 1) and up to Week 12 | Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12. |
| Change From Baseline in Fasting Insulin at Week 12 | Baseline (Day 1) and up to Week 12 | Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12. |
| Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Baseline (Day 1) and up to Week 12 | Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12. |
| Change From Baseline in Fructosamine at Week 6 and Week 12 | Baseline (Day -1) and Week 12 | Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12. |
| Number of Participants With HbA1c < 7.0% and < 6.5% | Up to Week 12 | Data has been presented for number of participants with their corresponding percentages with HbA1c \<7.0% and \<6.5%. |
| Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Baseline (Day 1) and up to Week 6 | Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6. |
Countries
France, Spain, United Kingdom, United States
Participant flow
Recruitment details
This was a study in participants with Type 2 diabetes mellitus which was conducted across 14 centers in 4 countries (France \[4\], Spain \[3\], United Kingdom \[4\], Unites States \[3\]) from 13 July 2011 to 17 September 2012. Total of 89 participants were included in the pharmacokinetic population.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Pooled) Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group. | 20 |
| GSK256073 5 mg BID Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state. | 18 |
| GSK256073 10 mg Once Daily Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state. | 19 |
| GSK256073 25 mg BID Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state. | 19 |
| GSK256073 50 mg Once Daily Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state. | 18 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo (Pooled) | Total | GSK256073 50 mg Once Daily | GSK256073 25 mg BID | GSK256073 10 mg Once Daily | GSK256073 5 mg BID |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.0 Years STANDARD_DEVIATION 7.01 | 58.8 Years STANDARD_DEVIATION 7.01 | 57.1 Years STANDARD_DEVIATION 7.3 | 60.2 Years STANDARD_DEVIATION 6.21 | 59.6 Years STANDARD_DEVIATION 8.07 | 60.0 Years STANDARD_DEVIATION 6.24 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 87 Participants | 18 Participants | 16 Participants | 19 Participants | 18 Participants |
| Sex: Female, Male Female | 4 Participants | 27 Participants | 1 Participants | 5 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 16 Participants | 67 Participants | 17 Participants | 14 Participants | 9 Participants | 11 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 11 / 20 | 12 / 18 | 12 / 19 | 10 / 19 | 10 / 18 |
| serious Total, serious adverse events | 1 / 20 | 0 / 18 | 0 / 19 | 2 / 19 | 0 / 18 |
Outcome results
Primary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12.
Time frame: Baseline (Day -1) and up to Week 12
Population: Pharmacodynamic (PD) population comprised of all participants who provide pharmacodynamic data. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Day 41 | -0.34 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.709 |
| Placebo (Pooled) | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 12 | -0.36 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.698 |
| Placebo (Pooled) | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 9 | -0.44 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.808 |
| GSK256073 5 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 9 | -0.24 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.608 |
| GSK256073 5 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Day 41 | -0.18 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.555 |
| GSK256073 5 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 12 | -0.14 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.778 |
| GSK256073 10 mg Once Daily | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 9 | -0.48 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.503 |
| GSK256073 10 mg Once Daily | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Day 41 | -0.37 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.443 |
| GSK256073 10 mg Once Daily | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 12 | -0.46 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.507 |
| GSK256073 25 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Day 41 | -0.42 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.423 |
| GSK256073 25 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 12 | -0.56 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.562 |
| GSK256073 25 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 9 | -0.56 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.512 |
| GSK256073 50 mg Once Daily | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 9 | -0.59 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.464 |
| GSK256073 50 mg Once Daily | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Day 41 | -0.44 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.37 |
| GSK256073 50 mg Once Daily | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Week 12 | -0.64 Percentage of Glycosylated Hemoglobin | Standard Deviation 0.63 |
95% CI: [-0.13, 0.6]
95% CI: [-0.37, 0.35]
95% CI: [-0.49, 0.23]
95% CI: [-0.66, 0.06]
Primary
Change From Baseline in Heart Rate
Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12.
Time frame: Baseline (pre-dose Day 1) and up to Week 12
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Change From Baseline in Heart Rate | Day 1,12 hours | 2.5 Beats per minute | Standard Deviation 5.39 |
| Placebo (Pooled) | Change From Baseline in Heart Rate | Day 2, 12 hours | 3.3 Beats per minute | Standard Deviation 6.8 |
| Placebo (Pooled) | Change From Baseline in Heart Rate | Day 6, pre-dose | -0.9 Beats per minute | Standard Deviation 6.53 |
| Placebo (Pooled) | Change From Baseline in Heart Rate | Week 12 | 2.8 Beats per minute | Standard Deviation 6.95 |
| Placebo (Pooled) | Change From Baseline in Heart Rate | Week 9 | 1.7 Beats per minute | Standard Deviation 6.44 |
| Placebo (Pooled) | Change From Baseline in Heart Rate | Day 2, pre-dose | 1.2 Beats per minute | Standard Deviation 4.79 |
| Placebo (Pooled) | Change From Baseline in Heart Rate | Day 6, 12 hours | 2.9 Beats per minute | Standard Deviation 6.56 |
| Placebo (Pooled) | Change From Baseline in Heart Rate | Week 3 | 3.2 Beats per minute | Standard Deviation 5.44 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Week 9 | 3.6 Beats per minute | Standard Deviation 8.71 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Day 2, pre-dose | 1.2 Beats per minute | Standard Deviation 6.93 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Week 12 | 1.1 Beats per minute | Standard Deviation 10.59 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Day 2, 12 hours | 1.9 Beats per minute | Standard Deviation 6.81 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Week 3 | 1.2 Beats per minute | Standard Deviation 8.41 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Day 1,12 hours | -1.0 Beats per minute | Standard Deviation 4.64 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Day 6, pre-dose | -1.6 Beats per minute | Standard Deviation 7.62 |
| GSK256073 5 mg BID | Change From Baseline in Heart Rate | Day 6, 12 hours | 2.2 Beats per minute | Standard Deviation 9.13 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Day 2, pre-dose | 2.6 Beats per minute | Standard Deviation 5.01 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Week 3 | 3.1 Beats per minute | Standard Deviation 7.47 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Week 12 | 4.1 Beats per minute | Standard Deviation 10.12 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Day 6, pre-dose | 0.5 Beats per minute | Standard Deviation 6.89 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Day 1,12 hours | 1.1 Beats per minute | Standard Deviation 7.77 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Week 9 | 4.9 Beats per minute | Standard Deviation 11.4 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Day 6, 12 hours | 3.3 Beats per minute | Standard Deviation 7.48 |
| GSK256073 10 mg Once Daily | Change From Baseline in Heart Rate | Day 2, 12 hours | 4.6 Beats per minute | Standard Deviation 7.02 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Day 2, 12 hours | 3.8 Beats per minute | Standard Deviation 7.62 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Day 6, 12 hours | 6.6 Beats per minute | Standard Deviation 11.16 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Week 12 | 3.9 Beats per minute | Standard Deviation 9.98 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Week 3 | 0.1 Beats per minute | Standard Deviation 4.81 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Day 1,12 hours | 1.3 Beats per minute | Standard Deviation 7.07 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Week 9 | 4.4 Beats per minute | Standard Deviation 9.26 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Day 2, pre-dose | 0.9 Beats per minute | Standard Deviation 6.99 |
| GSK256073 25 mg BID | Change From Baseline in Heart Rate | Day 6, pre-dose | 3.1 Beats per minute | Standard Deviation 14.29 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Week 12 | -0.5 Beats per minute | Standard Deviation 8.46 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Day 1,12 hours | 0.7 Beats per minute | Standard Deviation 7.93 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Day 2, pre-dose | 1.3 Beats per minute | Standard Deviation 7.74 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Day 2, 12 hours | 1.5 Beats per minute | Standard Deviation 7.71 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Week 3 | 1.2 Beats per minute | Standard Deviation 7.95 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Day 6, pre-dose | -1.2 Beats per minute | Standard Deviation 9.88 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Day 6, 12 hours | -3.8 Beats per minute | Standard Deviation 9.14 |
| GSK256073 50 mg Once Daily | Change From Baseline in Heart Rate | Week 9 | 3.2 Beats per minute | Standard Deviation 9.1 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12.
Time frame: Baseline (pre-dose Day 1) and up to Week 12
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, pre-dose | -0.1 Millimeters of mercury | Standard Deviation 11.26 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, pre-dose | -0.8 Millimeters of mercury | Standard Deviation 10.66 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, 12 hours | 0.7 Millimeters of mercury | Standard Deviation 11.84 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 3 | 3.7 Millimeters of mercury | Standard Deviation 13.68 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1,12 hours | 3.4 Millimeters of mercury | Standard Deviation 10.48 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, 12 hours | 6.6 Millimeters of mercury | Standard Deviation 15.32 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 9 | 4.0 Millimeters of mercury | Standard Deviation 11.93 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12 | 2.3 Millimeters of mercury | Standard Deviation 9.85 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1,12 hours | 1.4 Millimeters of mercury | Standard Deviation 6.66 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, pre-dose | -1.2 Millimeters of mercury | Standard Deviation 6.89 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, 12 hours | 0.8 Millimeters of mercury | Standard Deviation 6.17 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 3 | 2.2 Millimeters of mercury | Standard Deviation 6.59 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, pre-dose | 1.3 Millimeters of mercury | Standard Deviation 6.74 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, 12 hours | 2.9 Millimeters of mercury | Standard Deviation 7.94 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 9 | 3.3 Millimeters of mercury | Standard Deviation 7.63 |
| Placebo (Pooled) | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12 | 0.1 Millimeters of mercury | Standard Deviation 5.95 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, 12 hours | -1.7 Millimeters of mercury | Standard Deviation 8.01 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, pre-dose | -2.1 Millimeters of mercury | Standard Deviation 7.46 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1,12 hours | 0.6 Millimeters of mercury | Standard Deviation 7.42 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 9 | -2.8 Millimeters of mercury | Standard Deviation 8.79 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12 | -6.4 Millimeters of mercury | Standard Deviation 8.08 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, pre-dose | -7.7 Millimeters of mercury | Standard Deviation 12.96 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 3 | -3.9 Millimeters of mercury | Standard Deviation 11.83 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, pre-dose | -6.5 Millimeters of mercury | Standard Deviation 11.3 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1,12 hours | 0.9 Millimeters of mercury | Standard Deviation 10.73 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, pre-dose | -4.7 Millimeters of mercury | Standard Deviation 8.96 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, 12 hours | -2.5 Millimeters of mercury | Standard Deviation 14.05 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, 12 hours | -3.8 Millimeters of mercury | Standard Deviation 8.34 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12 | -3.4 Millimeters of mercury | Standard Deviation 8.69 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 3 | 0.3 Millimeters of mercury | Standard Deviation 5.32 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, 12 hours | -0.6 Millimeters of mercury | Standard Deviation 6.57 |
| GSK256073 5 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 9 | -9.1 Millimeters of mercury | Standard Deviation 14.02 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, 12 hours | 1.0 Millimeters of mercury | Standard Deviation 5.55 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 3 | 0.5 Millimeters of mercury | Standard Deviation 12.41 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, pre-dose | -3.4 Millimeters of mercury | Standard Deviation 9.07 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, 12 hours | 1.0 Millimeters of mercury | Standard Deviation 10.83 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 9 | -1.6 Millimeters of mercury | Standard Deviation 10.27 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12 | -0.3 Millimeters of mercury | Standard Deviation 7.95 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 9 | 0.1 Millimeters of mercury | Standard Deviation 7.66 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1,12 hours | 2.0 Millimeters of mercury | Standard Deviation 6 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, pre-dose | -2.1 Millimeters of mercury | Standard Deviation 5.27 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, 12 hours | 1.4 Millimeters of mercury | Standard Deviation 4.89 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 3 | -0.1 Millimeters of mercury | Standard Deviation 8.42 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, pre-dose | -0.4 Millimeters of mercury | Standard Deviation 6.82 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1,12 hours | 4.9 Millimeters of mercury | Standard Deviation 19.88 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12 | 0.7 Millimeters of mercury | Standard Deviation 6.51 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, pre-dose | -7.7 Millimeters of mercury | Standard Deviation 10.97 |
| GSK256073 10 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, 12 hours | 1.1 Millimeters of mercury | Standard Deviation 11.76 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, pre-dose | -1.7 Millimeters of mercury | Standard Deviation 5.15 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12 | 0.9 Millimeters of mercury | Standard Deviation 7.03 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, 12 hours | 0.8 Millimeters of mercury | Standard Deviation 5.65 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, 12 hours | 0.6 Millimeters of mercury | Standard Deviation 5.8 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 3 | -0.5 Millimeters of mercury | Standard Deviation 6.75 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, 12 hours | 2.7 Millimeters of mercury | Standard Deviation 12.76 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, pre-dose | -2.0 Millimeters of mercury | Standard Deviation 9.56 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 3 | -1.7 Millimeters of mercury | Standard Deviation 10.71 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1,12 hours | 3.0 Millimeters of mercury | Standard Deviation 12.9 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, 12 hours | 1.7 Millimeters of mercury | Standard Deviation 7.86 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12 | 2.8 Millimeters of mercury | Standard Deviation 13.13 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, pre-dose | -5.3 Millimeters of mercury | Standard Deviation 16.93 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1,12 hours | -0.5 Millimeters of mercury | Standard Deviation 7.69 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 9 | -0.9 Millimeters of mercury | Standard Deviation 8.23 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 9 | -2.0 Millimeters of mercury | Standard Deviation 11.73 |
| GSK256073 25 mg BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, pre-dose | -1.7 Millimeters of mercury | Standard Deviation 7.73 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, pre-dose | -1.4 Millimeters of mercury | Standard Deviation 4.73 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, pre-dose | -0.2 Millimeters of mercury | Standard Deviation 6.37 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 9 | -1.2 Millimeters of mercury | Standard Deviation 7.65 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, pre-dose | -5.8 Millimeters of mercury | Standard Deviation 8.19 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, pre-dose | -4.7 Millimeters of mercury | Standard Deviation 9.25 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12 | 0.4 Millimeters of mercury | Standard Deviation 10.59 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2, 12 hours | 2.0 Millimeters of mercury | Standard Deviation 6.62 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12 | 0.3 Millimeters of mercury | Standard Deviation 6.3 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6, 12 hours | 1.6 Millimeters of mercury | Standard Deviation 7.51 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 1,12 hours | 3.2 Millimeters of mercury | Standard Deviation 8.55 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 1,12 hours | 1.9 Millimeters of mercury | Standard Deviation 11.04 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 3 | 1.0 Millimeters of mercury | Standard Deviation 6.43 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 9 | -3.8 Millimeters of mercury | Standard Deviation 10.57 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6, 12 hours | 1.5 Millimeters of mercury | Standard Deviation 7.37 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 3 | -1.1 Millimeters of mercury | Standard Deviation 8.78 |
| GSK256073 50 mg Once Daily | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2, 12 hours | -1.8 Millimeters of mercury | Standard Deviation 11.16 |
Primary
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings
Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented.
Time frame: Up to Week 20
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | normal | 12 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal clinically significant | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal not clinically significant | 6 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | normal | 14 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | normal | 10 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal clinically significant | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal clinically significant | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal not clinically significant | 3 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | normal | 16 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal not clinically significant | 8 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal not clinically significant | 8 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal clinically significant | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal not clinically significant | 3 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | normal | 17 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal clinically significant | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | normal | 14 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | normal | 14 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal not clinically significant | 4 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal clinically significant | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | normal | 14 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal not clinically significant | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal clinically significant | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal not clinically significant | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal clinically significant | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | normal | 14 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal not clinically significant | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal clinically significant | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | normal | 14 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal not clinically significant | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal clinically significant | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal clinically significant | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal clinically significant | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | normal | 14 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal not clinically significant | 3 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | normal | 13 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal not clinically significant | 3 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | normal | 13 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal not clinically significant | 3 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal clinically significant | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | normal | 13 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal not clinically significant | 6 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal not clinically significant | 5 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal clinically significant | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal clinically significant | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | normal | 13 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal clinically significant | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal clinically significant | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal not clinically significant | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal not clinically significant | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal not clinically significant | 3 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal clinically significant | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | normal | 12 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | normal | 18 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal not clinically significant | 4 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal clinically significant | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | normal | 12 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | normal | 16 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal clinically significant | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | normal | 16 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal not clinically significant | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | normal | 13 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | normal | 12 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal clinically significant | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal not clinically significant | 6 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal clinically significant | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | normal | 14 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 3 | abnormal not clinically significant | 4 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 1 | abnormal not clinically significant | 6 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | normal | 12 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal not clinically significant | 6 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | normal | 12 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal clinically significant | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 12 | abnormal not clinically significant | 3 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Day 2 | abnormal clinically significant | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Electrocardiograms (ECGs) Findings | Week 6 | abnormal clinically significant | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick
Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL).
Time frame: Up to Week 12
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 3+ | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 2+ or 1/2 g/dL | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 3+ or 1 g/dL | 3 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace or 1/10 g/dL | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 3+ | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 2+ | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 3+ or 1 g/dL | 3 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 2+ or 1/2 g/dL | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 2+ | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 1+ | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Negative | 13 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Negative | 13 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Negative | 13 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, 1+ or 1/4 | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Trace | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 1+ or 1/4 | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, 1+ | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 1+ | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Negative | 18 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace or 1/10 g/dL | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 1+ | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Trace | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, 1+ | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 1+ or 1/4 g/dL | 2 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Negative | 18 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 1+ or 1/4 g/dL | 2 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Trace | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Trace | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 2+ or 1/2 g/dL | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Trace | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace or 1/10 g/dL | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Trace | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Negative | 17 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 3+ or 1 g/dL | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 2+ | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Negative | 18 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Negative | 17 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Trace | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Negative | 18 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 1+ or 1/4 g/dL | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Negative | 15 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 2+ | 0 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Negative | 19 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Trace | 1 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Negative | 17 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Trace | 2 Participants |
| Placebo (Pooled) | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, 1+ | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, 1+ | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, 1+ | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Trace | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Negative | 15 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 2+ or 1/2 g/dL | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Negative | 17 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Trace | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, 1+ or 1/4 | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Trace | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 1+ or 1/4 | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Negative | 12 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Negative | 14 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 2+ | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 3+ or 1 g/dL | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 2+ | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Negative | 12 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 1+ | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Negative | 11 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Trace | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace or 1/10 g/dL | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 2+ | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Negative | 12 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 1+ or 1/4 g/dL | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 3+ | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 2+ | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 3+ or 1 g/dL | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace or 1/10 g/dL | 4 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 1+ | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Negative | 13 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Trace | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 1+ | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Negative | 13 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace or 1/10 g/dL | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, 1+ | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 1+ or 1/4 g/dL | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Trace | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 1+ or 1/4 g/dL | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Negative | 15 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 3+ or 1 g/dL | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 3+ | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Trace | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Negative | 17 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Trace | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Negative | 15 Participants |
| GSK256073 5 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 1+ | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Negative | 14 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace or 1/10 g/dL | 2 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 1+ or 1/4 g/dL | 2 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 2+ or 1/2 g/dL | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 3+ or 1 g/dL | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Negative | 13 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace or 1/10 g/dL | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 1+ or 1/4 g/dL | 2 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 3+ or 1 g/dL | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Negative | 13 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace or 1/10 g/dL | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 1+ or 1/4 g/dL | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 2+ or 1/2 g/dL | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 3+ or 1 g/dL | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Negative | 19 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, 1+ | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Negative | 13 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Trace | 2 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 1+ or 1/4 | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 2+ | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Negative | 15 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, 1+ or 1/4 | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Negative | 16 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Trace | 3 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, 1+ | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Negative | 15 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Trace | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Negative | 15 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, 1+ | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Negative | 12 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Trace | 4 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 1+ | 2 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 2+ | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 3+ | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Negative | 13 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Trace | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 2+ | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Negative | 14 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Trace | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 1+ | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 2+ | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 3+ | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Negative | 10 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace or 1/10 g/dL | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 1+ or 1/4 g/dL | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 3+ | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Trace | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, 1+ | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace or 1/10 g/dL | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 3+ | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Negative | 15 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Negative | 18 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 1+ or 1/4 g/dL | 3 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 2+ | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Trace | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace or 1/10 g/dL | 3 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Negative | 12 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 1+ | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 1+ | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Negative | 14 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 3+ or 1 g/dL | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Trace | 3 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 2+ | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Negative | 8 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Negative | 12 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 2+ | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Trace | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Negative | 15 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Negative | 12 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Trace | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 1+ or 1/4 | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, 1+ or 1/4 | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Trace | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 3+ or 1 g/dL | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 1+ or 1/4 g/dL | 3 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Trace | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 1+ | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, 1+ | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Trace | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Negative | 14 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Negative | 9 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Negative | 17 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 2+ or 1/2 g/dL | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 3+ or 1 g/dL | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, 1+ | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 2+ | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Trace | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Trace | 3 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Trace | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 1+ or 1/4 g/dL | 2 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, 1+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, Negative | 17 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Negative | 17 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 3+ or 1 g/dL | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day 41, Trace | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Negative | 16 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, 1+ or 1/4 g/dL | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Trace | 2 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, Trace | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace or 1/10 g/dL | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace or 1/10 g/dL | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Week 12, 1+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Trace | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Negative | 14 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Week 12, Negative | 15 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 3+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, Trace | 4 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 3+ or 1 g/dL | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 1+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 1+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Trace | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 2+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, 1+ or 1/4 g/dL | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day -1, 3+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace or 1/10 g/dL | 2 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Negative | 14 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Trace | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, Trace | 3 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day 41, Negative | 13 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 1+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 3+ or 1 g/dL | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, 2+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Day 41, 2+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 2+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, 1+ or 1/4 | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, 2+ or 1/2 g/dL | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Negative | 12 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, Trace | 3 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Trace | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine glucose, Day -1, Negative | 14 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Week 12, 1+ or 1/4 | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day 41, Negative | 14 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine occult blood, Day -1, Negative | 18 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine ketones, Day -1, 1+ | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick | Urine protein, Week 12, Negative | 14 Participants |
Primary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
Time frame: Up to Week 12
Population: Safety population was used which was defined as all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Pooled) | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 11 Participants |
| Placebo (Pooled) | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 12 Participants |
| GSK256073 5 mg BID | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 12 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 11 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 10 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
Primary
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (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, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12. Data for parameters with high and low of PCI is provided.
Time frame: Up to Week 12
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Pooled) | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, high | 1 Participants |
| Placebo (Pooled) | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Total bilirubin, high | 0 Participants |
| Placebo (Pooled) | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatine kinase, high | 2 Participants |
| Placebo (Pooled) | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatinine, high | 1 Participants |
| Placebo (Pooled) | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, low | 1 Participants |
| Placebo (Pooled) | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Albumin, low | 2 Participants |
| GSK256073 5 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, low | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatine kinase, high | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatinine, high | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Albumin, low | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Total bilirubin, high | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, high | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatinine, high | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Total bilirubin, high | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, low | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Albumin, low | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, high | 1 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatine kinase, high | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatinine, high | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatine kinase, high | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, high | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, low | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Total bilirubin, high | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Albumin, low | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Total bilirubin, high | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, high | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Potassium, low | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Albumin, low | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatine kinase, high | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) | Creatinine, high | 0 Participants |
Primary
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (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, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided.
Time frame: Up to Week 12
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Pooled) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Total neutrophils, low | 3 Participants |
| Placebo (Pooled) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Platelet count, low | 1 Participants |
| Placebo (Pooled) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Lymphocytes, low | 0 Participants |
| Placebo (Pooled) | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | WBC, low | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Total neutrophils, low | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | WBC, low | 0 Participants |
| GSK256073 5 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Platelet count, low | 1 Participants |
| GSK256073 5 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Lymphocytes, low | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | WBC, low | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Platelet count, low | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Lymphocytes, low | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Total neutrophils, low | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Total neutrophils, low | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Platelet count, low | 0 Participants |
| GSK256073 25 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | WBC, low | 1 Participants |
| GSK256073 25 mg BID | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Lymphocytes, low | 2 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | WBC, low | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Lymphocytes, low | 0 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Platelet count, low | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) | Total neutrophils, low | 0 Participants |
Secondary
Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6
Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6.
Time frame: Baseline (Day 1) and up to Week 6
Population: PD population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Day 2 | 0.462 Millimoles per liter | Standard Deviation 1.0525 |
| Placebo (Pooled) | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Week 6 | 0.009 Millimoles per liter | Standard Deviation 1.8099 |
| Placebo (Pooled) | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Day 2 | -0.0152 Millimoles per liter | Standard Deviation 0.08082 |
| Placebo (Pooled) | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Week 6 | -0.0457 Millimoles per liter | Standard Deviation 0.07154 |
| GSK256073 5 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Day 2 | -0.502 Millimoles per liter | Standard Deviation 2.0948 |
| GSK256073 5 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Week 6 | -0.0342 Millimoles per liter | Standard Deviation 0.17352 |
| GSK256073 5 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Week 6 | -0.786 Millimoles per liter | Standard Deviation 3.1101 |
| GSK256073 5 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Day 2 | -0.1307 Millimoles per liter | Standard Deviation 0.09016 |
| GSK256073 10 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Week 6 | -0.0423 Millimoles per liter | Standard Deviation 0.08431 |
| GSK256073 10 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Week 6 | -0.502 Millimoles per liter | Standard Deviation 1.2995 |
| GSK256073 10 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Day 2 | -0.1326 Millimoles per liter | Standard Deviation 0.12437 |
| GSK256073 10 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Day 2 | 0.036 Millimoles per liter | Standard Deviation 1.0464 |
| GSK256073 25 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Day 2 | -0.517 Millimoles per liter | Standard Deviation 0.8577 |
| GSK256073 25 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Week 6 | -0.647 Millimoles per liter | Standard Deviation 1.0043 |
| GSK256073 25 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Week 6 | -0.0293 Millimoles per liter | Standard Deviation 0.22736 |
| GSK256073 25 mg BID | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Day 2 | -0.1926 Millimoles per liter | Standard Deviation 0.1382 |
| GSK256073 50 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Week 6 | -0.1032 Millimoles per liter | Standard Deviation 0.11673 |
| GSK256073 50 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | NEFA, Day 2 | -0.1503 Millimoles per liter | Standard Deviation 0.0972 |
| GSK256073 50 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Week 6 | -0.544 Millimoles per liter | Standard Deviation 1.3403 |
| GSK256073 50 mg Once Daily | Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 | Glucose, Day 2 | -0.076 Millimoles per liter | Standard Deviation 0.9745 |
95% CI: [-1.645, 0.543]
95% CI: [-1.472, 0.708]
95% CI: [-1.696, 0.516]
95% CI: [-1.669, 0.48]
95% CI: [-0.042, 0.113]
95% CI: [-0.073, 0.081]
95% CI: [-0.058, 0.099]
95% CI: [-0.16, -0.007]
Secondary
Change From Baseline in Fasting Insulin at Week 12
Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.
Time frame: Baseline (Day 1) and up to Week 12
Population: PD population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Change From Baseline in Fasting Insulin at Week 12 | Day 2 | -1.1 Picomoles per liter | Standard Deviation 73.81 |
| Placebo (Pooled) | Change From Baseline in Fasting Insulin at Week 12 | Week 12 | 27.3 Picomoles per liter | Standard Deviation 139.3 |
| Placebo (Pooled) | Change From Baseline in Fasting Insulin at Week 12 | Week 6 | -3.9 Picomoles per liter | Standard Deviation 25.74 |
| GSK256073 5 mg BID | Change From Baseline in Fasting Insulin at Week 12 | Week 6 | -9.1 Picomoles per liter | Standard Deviation 38.84 |
| GSK256073 5 mg BID | Change From Baseline in Fasting Insulin at Week 12 | Day 2 | 19.1 Picomoles per liter | Standard Deviation 52.1 |
| GSK256073 5 mg BID | Change From Baseline in Fasting Insulin at Week 12 | Week 12 | 14.7 Picomoles per liter | Standard Deviation 38.66 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fasting Insulin at Week 12 | Week 6 | 2.9 Picomoles per liter | Standard Deviation 20.77 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fasting Insulin at Week 12 | Day 2 | 6.6 Picomoles per liter | Standard Deviation 34.9 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fasting Insulin at Week 12 | Week 12 | -2.0 Picomoles per liter | Standard Deviation 25.8 |
| GSK256073 25 mg BID | Change From Baseline in Fasting Insulin at Week 12 | Day 2 | -2.8 Picomoles per liter | Standard Deviation 26.41 |
| GSK256073 25 mg BID | Change From Baseline in Fasting Insulin at Week 12 | Week 12 | 33.4 Picomoles per liter | Standard Deviation 80.94 |
| GSK256073 25 mg BID | Change From Baseline in Fasting Insulin at Week 12 | Week 6 | -6.0 Picomoles per liter | Standard Deviation 50.97 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fasting Insulin at Week 12 | Week 6 | 2.6 Picomoles per liter | Standard Deviation 78.83 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fasting Insulin at Week 12 | Day 2 | 0.2 Picomoles per liter | Standard Deviation 22.75 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fasting Insulin at Week 12 | Week 12 | 4.7 Picomoles per liter | Standard Deviation 43.42 |
95% CI: [-48.62, 53.16]
95% CI: [-58.04, 42.7]
95% CI: [-27.75, 75.92]
95% CI: [-52.72, 48.53]
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 12
Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.
Time frame: Baseline (Day 1) and up to Week 12
Population: PD population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Change From Baseline in Fasting Plasma Glucose at Week 12 | Day 2 | 0.09 Millimoles per liter | Standard Deviation 0.723 |
| Placebo (Pooled) | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 12 | -0.64 Millimoles per liter | Standard Deviation 1.439 |
| Placebo (Pooled) | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 6 | -0.25 Millimoles per liter | Standard Deviation 1.933 |
| GSK256073 5 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 6 | -0.82 Millimoles per liter | Standard Deviation 2.91 |
| GSK256073 5 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | Day 2 | -0.05 Millimoles per liter | Standard Deviation 1.186 |
| GSK256073 5 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 12 | -0.85 Millimoles per liter | Standard Deviation 2.547 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 6 | -1.06 Millimoles per liter | Standard Deviation 1.472 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fasting Plasma Glucose at Week 12 | Day 2 | 0.04 Millimoles per liter | Standard Deviation 1.019 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 12 | -0.71 Millimoles per liter | Standard Deviation 1.29 |
| GSK256073 25 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | Day 2 | 0.04 Millimoles per liter | Standard Deviation 1.611 |
| GSK256073 25 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 12 | -0.44 Millimoles per liter | Standard Deviation 0.913 |
| GSK256073 25 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 6 | -0.62 Millimoles per liter | Standard Deviation 1.289 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 6 | -0.91 Millimoles per liter | Standard Deviation 1.03 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fasting Plasma Glucose at Week 12 | Day 2 | -0.34 Millimoles per liter | Standard Deviation 0.59 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fasting Plasma Glucose at Week 12 | Week 12 | -0.83 Millimoles per liter | Standard Deviation 1.497 |
95% CI: [-0.79, 0.94]
95% CI: [-0.9, 0.82]
95% CI: [-0.9, 0.85]
95% CI: [-1.27, 0.42]
Secondary
Change From Baseline in Fructosamine at Week 6 and Week 12
Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12.
Time frame: Baseline (Day -1) and Week 12
Population: PD population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Change From Baseline in Fructosamine at Week 6 and Week 12 | Day 41 | -14.9 Micromoles per liter | Standard Deviation 33.59 |
| Placebo (Pooled) | Change From Baseline in Fructosamine at Week 6 and Week 12 | Week 12 | -22.3 Micromoles per liter | Standard Deviation 27.92 |
| GSK256073 5 mg BID | Change From Baseline in Fructosamine at Week 6 and Week 12 | Day 41 | -18.8 Micromoles per liter | Standard Deviation 34.49 |
| GSK256073 5 mg BID | Change From Baseline in Fructosamine at Week 6 and Week 12 | Week 12 | -16.4 Micromoles per liter | Standard Deviation 37.43 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fructosamine at Week 6 and Week 12 | Day 41 | -21.2 Micromoles per liter | Standard Deviation 24.51 |
| GSK256073 10 mg Once Daily | Change From Baseline in Fructosamine at Week 6 and Week 12 | Week 12 | -30.7 Micromoles per liter | Standard Deviation 21.71 |
| GSK256073 25 mg BID | Change From Baseline in Fructosamine at Week 6 and Week 12 | Week 12 | -25.4 Micromoles per liter | Standard Deviation 33.74 |
| GSK256073 25 mg BID | Change From Baseline in Fructosamine at Week 6 and Week 12 | Day 41 | -26.3 Micromoles per liter | Standard Deviation 25.73 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fructosamine at Week 6 and Week 12 | Day 41 | -21.1 Micromoles per liter | Standard Deviation 26.39 |
| GSK256073 50 mg Once Daily | Change From Baseline in Fructosamine at Week 6 and Week 12 | Week 12 | -36.1 Micromoles per liter | Standard Deviation 37.23 |
95% CI: [-19.36, 16.2]
95% CI: [-33, 2.81]
95% CI: [-32.41, 4.23]
95% CI: [-36.55, -1.68]
Secondary
GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship
The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected.
Time frame: Up to Week 12
Population: PD population. The data for this outcome measure was not collected.
Secondary
Number of Participants With HbA1c < 7.0% and < 6.5%
Data has been presented for number of participants with their corresponding percentages with HbA1c \<7.0% and \<6.5%.
Time frame: Up to Week 12
Population: PD population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Pooled) | Number of Participants With HbA1c < 7.0% and < 6.5% | <6.5% | 2 Participants |
| Placebo (Pooled) | Number of Participants With HbA1c < 7.0% and < 6.5% | <7% | 4 Participants |
| GSK256073 5 mg BID | Number of Participants With HbA1c < 7.0% and < 6.5% | <7% | 3 Participants |
| GSK256073 5 mg BID | Number of Participants With HbA1c < 7.0% and < 6.5% | <6.5% | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With HbA1c < 7.0% and < 6.5% | <6.5% | 0 Participants |
| GSK256073 10 mg Once Daily | Number of Participants With HbA1c < 7.0% and < 6.5% | <7% | 2 Participants |
| GSK256073 25 mg BID | Number of Participants With HbA1c < 7.0% and < 6.5% | <7% | 3 Participants |
| GSK256073 25 mg BID | Number of Participants With HbA1c < 7.0% and < 6.5% | <6.5% | 1 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With HbA1c < 7.0% and < 6.5% | <6.5% | 4 Participants |
| GSK256073 50 mg Once Daily | Number of Participants With HbA1c < 7.0% and < 6.5% | <7% | 11 Participants |
Secondary
Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12
Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.
Time frame: Baseline (Day 1) and up to Week 12
Population: PD population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Pooled) | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Day 2 | 0.2 Index | Standard Deviation 4.24 |
| Placebo (Pooled) | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 12 | -0.0 Index | Standard Deviation 3.57 |
| Placebo (Pooled) | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 6 | -0.6 Index | Standard Deviation 3.13 |
| GSK256073 5 mg BID | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 6 | -1.4 Index | Standard Deviation 4.11 |
| GSK256073 5 mg BID | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Day 2 | 1.1 Index | Standard Deviation 3.83 |
| GSK256073 5 mg BID | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 12 | 0.0 Index | Standard Deviation 2.47 |
| GSK256073 10 mg Once Daily | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 6 | -0.3 Index | Standard Deviation 1.75 |
| GSK256073 10 mg Once Daily | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Day 2 | 0.3 Index | Standard Deviation 1.98 |
| GSK256073 10 mg Once Daily | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 12 | -0.3 Index | Standard Deviation 2.08 |
| GSK256073 25 mg BID | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Day 2 | -0.2 Index | Standard Deviation 1.73 |
| GSK256073 25 mg BID | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 12 | 1.5 Index | Standard Deviation 4.17 |
| GSK256073 25 mg BID | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 6 | -0.4 Index | Standard Deviation 3.46 |
| GSK256073 50 mg Once Daily | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 6 | -0.7 Index | Standard Deviation 3.76 |
| GSK256073 50 mg Once Daily | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Day 2 | -0.2 Index | Standard Deviation 1.33 |
| GSK256073 50 mg Once Daily | Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 | Week 12 | -0.1 Index | Standard Deviation 3.44 |