Diabetes Mellitus, Type 2
Conditions
Keywords
Pioglitazone, HbA1c, Diabetes mellitus
Brief summary
This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with a documented diagnosis of T2DM and have an HbA1c level at Visit 1 of ≥7.0% and ≤9.5% as measured by a central laboratory. Subjects with HbA1c \<7.5% must have a fasting fingerstick glucose ≥7 mmol/L (126 mg/dL) at Week 0 prior to randomization. * Subjects who are treatment-naïve and have not taken insulin, or any oral or injectable anti-diabetic medication in the past 3 months and have not taken a glucose lowering agent for ≥4 weeks at any time in the past, or Subjects who are newly diagnosed and treated with diet and exercise for a minimum of 6 weeks * Subjects who are 18 to 70 years of age inclusive at the time of Screening. * Females of non-childbearing and childbearing potential are eligible to participate as follows: * Women of childbearing potential must be willing to use one of the following contraception methods: intrauterine device, condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent for at least 30 days prior to the start of study medication, throughout the study and the follow-up visit. Note: use of oral contraceptives is not permitted. * Women of non-child bearing potential are defined as follows: females regardless of age, with functioning ovaries and who have a current documented tubal ligation \[Hatcher, 2004\] bilateral oophorectomy or total hysterectomy, or females who are post-menopausal). (Post-menopausal is defined as after one year without menses with an appropriate clinical profile, e.g. age appropriate, \>45 years, in the absence of hormone replacement therapy. In addition to the above criteria, if the post-menopausal status is still questionable, a blood sample should be drawn for simultaneous measurement of follicle stimulating hormone and estradiol; values considered to confirm the post-menopausal state are respectively: FSH \>40 MIU/mL and estradiol \<40pg/mL (\<140 pmol/L)). * Informed Consent: a signed and dated written consent must be obtained from the subject before any procedures are performed.
Exclusion criteria
* Metabolic Disease * Diagnosis of Type 1 diabetes mellitus. * History of ketoacidosis which has required hospitalization. * Thyroid disorder \[TSH below the lower limit of the reference range (LLRR) of 0.4mIU/L or above the upper limit of the reference range (ULRR) of \>5.5 mIU/L at Screening\]. Hypothyroidism treated with the same dose and regimen of thyroid hormone replacement for at least 3 months prior to Screening is allowed. * BMI of \<22 or \>43 kg/m2. * Significant weight gain or loss (as defined as \>5% of total body weight) in the 3 months prior to Screening. * Diabetic Medication * Has taken insulin or any oral or injectable anti-diabetic medication ≥4 weeks at any time prior to screening. * Has taken insulin or any oral or injectable anti-diabetic medication within 3 months of screening. * Cardiovascular Disease * Recent history or presence of clinically significant acute cardiovascular disease including: 1. Documented myocardial infarction in the 6 months prior to Screening. 2. Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery either planned and/or occurred in the 6 months prior to Screening. 3. Unstable angina in the 6 months prior to Screening. 4. Clinically significant supraventricular arrhythmias requiring medical therapy, or history of nonsustained or sustained ventricular tachycardia. Symptomatic valvular heart disease or valvular heart disease requiring therapy other than endocarditis prophylaxis. 5. Congestive heart failure (CHF, New York Heart Association (NYHA) Class II to IV) requiring pharmacologic treatment. NYHA Class I may be included in accordance with the local prescribing information for pioglitazone. 6. Blood pressure (BP) \>150/100mmHg. If a subject is receiving permitted antihypertensive therapy, then they must be on stable dose(s) of therapy for at least 4 weeks prior to Screening. 7. Has a QTc interval (Bazett's) ≥450msec at Screening on a single ECG or an average value from 3 ECGs taken 5 minutes apart (on local reading of ECG). 8. Other clinically significant ECG abnormalities which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise contraindicates participation in a clinical trial with a new chemical entity. * Fasting triglycerides ≥400mg/dL (4.56mmol/L) at Screening. If a subject is receiving permitted lipid-lowering therapy, then they must be on a stable dose(s) of therapy for at least 6 weeks prior to Screening. Niacin and bile acid sequestrants are prohibited. * Hepatic Disease Has a diagnosis of active hepatitis (hepatitis B surface antigen or hepatitis C antibody), or clinically significant hepatic enzyme elevation including: Any one of the following enzymes greater than 2 times the upper limit of the reference range (ULRR) value at Screening. * alanine transaminase (ALT). * aspartate transaminase (AST). * alkaline phosphatase (AP). Has a total bilirubin level that is \>1.5 times the ULRR at Screening with the exception of suspected or confirmed Gilbert's disease. * Pancreatic Disease * Secondary causes of diabetes: * history of chronic or acute pancreatitis * Renal Disease * Significant renal disease at Screening as manifested by: Glomerular filtration rate (GFR) \<60mL/min (as estimated from serum creatinine at Visit 1 and demographic data using the MDRD equation).For the MDRD equation, please refer to the study procedures manual. Proteinuria of ≥1+ by urinary dipstick * Recurrent genitourinary tract infections defined as ≥2 episodes of complicated or uncomplicated cystitis or pyelonephritis in the 6 months prior to Screening * A positive qualitative urinary dipstick for leukocytes, red blood cells (RBC) or nitrites at Screening. * Concurrent Disease * Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests (including blood electrolytes), electrocardiogram, including pulmonary, neurological or inflammatory diseases, which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise contraindicates participation in a clinical trial with a new chemical entity * History of significant co-morbid diseases active in the 6 months prior to Screening (e.g., cholecystitis, acute pancreatitis, gastrointestinal disease, chronic diarrhea, etc.) * Has a history of malignancy within the past five years \[other than superficial squamous cell carcinoma which is non-invasive on pathology or basal cell carcinoma which is successfully treated with local excision\] and cervical cancer in situ treated definitively at least 6 months prior to Screening * Concurrent Medication * Is currently taking or has taken any of the following medications in the 8 weeks prior to Screening: 1. Digoxin 2. Warfarin and other oral anticoagulants (aspirin and non-steroidal anti-inflammatory drugs are permitted) 3. Bile acid sequestrants 4. Niacin (excluding routine vitamin supplementation) 5. Antiobesity agents (including fat absorption blocking agents) 6. Oral or injectable corticosteroids (inhaled and intranasal corticosteroids are permitted) 7. Loop diuretics 8. Monoamine oxidase inhibitors and tricyclic amines 9. Antiretroviral drugs 10. St John's Wort 11. Oral chromium * Pregnancy & Breast Feeding * Is currently lactating or pregnant * Other * Current smoker who is unable to abstain from smoking while in the clinic at each visit * Has a history of alcohol or substance abuse within the past year at Screening or alcohol or substance abuse during treatment, as determined by the investigator: * Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study. * Has an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine * Has participated in any study with an investigational or marketed drug in the 3 months prior to Screening * In the opinion of the investigator has a risk of non-compliance with study procedures, or cannot read, understand, or complete study related materials, particularly the informed consent * Known allergy to any of the tablet excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | Baseline (Week 0) and Week 12 | Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Only those participants with a value at Baseline and at Week 12 (after Last Observation Carried Forward \[LOCF\]) were used for this analysis. Adjusted mean is presented as least square mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Baseline (Week 0) and Week 4, Week 8 and Week 12 | Fasted blood samples for FPG were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline to Week 12 in Fructosamine | Baseline (Week 0) to Week 12 | Fasted blood samples for fructosamine were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline to Week 12 in Fasting Insulin | Baseline (Week 0) to Week 12 | Fasted blood samples for insulin were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Week 12 | Fasted blood samples for HbA1c were collected at Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Number of participants at Week 12 with: HbA1c \<= 6.5%, HbA1c \<7.0%; FPG \<7 mmo/L (126 milligram/deciliter \[mg/dL\]), FPG \<7.8 mmol/L (140 mg/dL); FPG \<5.5 mmol/L (100 mg/dL); a decrease from Baseline of HbA1c \>= 0.7%; a decrease from Baseline of FPG ≥1.7 mmol/L (30 mg/dL) are presented. |
| Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | Baseline (Week 0) and Week 4, Week 8 and Week 12 | Fasted samples for TC, LDL-C, HDL-C and TG were collected at Week 12. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent Change based on log-transformed data: 100\*(exponentiated(mean change on log scale)-1) |
| Change From Baseline to Week 12 in Body Weight | Baseline (Week 0) to Week 12 | Weight of participants was measured from Baseline (Week 0) to Week 12 and recorded in the case report form (CRF). Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline to Week 12 in Waist Circumference | Baseline (Week 0) to Week 12 | Waist circumference of participants was measured from Baseline (Week 0) to Week 12 and recorded in the CRF. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | Baseline (Week 0) and Week 12 (24-hour urine collection) | A 24-hour urine collection was obtained from all participants at Baseline (Week 0) and Week 12 to measure glucose. Participants were provided with urine collection bottles and cooler prior to these visits and instructed that the urine collections must be kept cold and dropped off at the clinic prior to or at the scheduled visits. Site staff queried participants to determine whether the sample represented a full 24-hour collection. The total volume and the sample date and time were recorded. The entire 24-hour urine collection was well mixed in one container and a urine aliquot obtained. Samples were assayed for glucose. The 24-hour collections were used to derive 24-hour urine glucose excretion corrected for filtered load. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Baseline (Week 0) and Week 4 and Week 8 | Fasted blood samples for HbA1c were collected at Baseline and Weeks 4 and 8. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline in Insulin AUC During a 2-hour OGTT | Baseline (Week 0) and Week 12 (0 to 2-hour OGTT) | Post-prandial assessments of insulin were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline in C-peptide AUC During a 2-hr OGTT | Baseline (Week 0) and Week 12 (0 to 2 hour OGTT) | Post-prandial assessments of C-peptide were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 12 weeks | AE is 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. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is 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, or is a congenital anomaly/birth defect or is medically significant. |
| Number of Participants With On-therapy Hypoglycemia | Up to 14 weeks | Hypoglycemia is low blood glucose or low blood sugar. Hypoglycemic events were collected separately and reported separately from AE, including supplemental data which were not collected for AE. However, any hypoglycemic event which met the criteria for a SAE was included in the SAE summaries. The number of participants in each group that experienced a hypoglycemic event was summarized by frequency of the events. |
| Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Up to 14 weeks | Vital signs included heart rate and blood pressure. Heart rate and blood pressure were taken before blood draws were performed. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. Heart rate and blood pressure was measured pre-dose in duplicate at the specified visits, after the participant had been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Heart rate was measured at the same time as blood pressure using the standardized blood pressure equipment that was provided. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | Up to Early withdrawal (Between Week 12 and Week 14) | Full 12-lead ECGs were recorded at screening, Baseline (Week 0), Week 4, Week 12 or early withdrawal, and Week 14 (Follow-up) using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was \>500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was \>500 msec, the participant was withdrawn from the study. |
| Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Up to 14 weeks | Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. An additional fasting blood sample (serum and plasma) was drawn at Week 0, Week 4, Week 6 and Week 12 or at early withdrawal (up to 14 weeks) and kept in long-term storage for future testing of biomarkers for diabetes and complications of the disease. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
| Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | Baseline (Week 0) and Week 12 (0 to 2 hour OGTT) | Post-prandial assessments of glucose were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. |
Countries
Argentina, Bulgaria, Chile, Costa Rica, Czechia, Germany, Hungary, India, Latvia, Lithuania, Mexico, New Zealand, Peru, Poland, Puerto Rico, Romania, Russia, South Africa, United States
Participant flow
Recruitment details
This study was conducted at 121 centers of which 95 randomized participants, in 18 countries (9 European, 8 International, and the United States) from 23 January 2007 to 14 February 2008.
Pre-assignment details
The Screening period was of 2 weeks. A glucose meter and detailed instructions for use were provided to all participants at the Screening visit for self- monitoring of fasting blood glucose levels and a Daily Glucose Monitoring Log for recording blood glucose information. Dietary and exercise advice was provided at randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks. | 48 |
| GSK189075 50 mg Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks. | 47 |
| GSK189075 100 mg Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks. | 48 |
| GSK189075 250 mg Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks. | 48 |
| GSK189075 500 mg Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks. | 48 |
| GSK189075 1000 mg Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks. | 47 |
| Pioglitazone 30 mg Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks. | 48 |
| Total | 334 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 1 | 2 | 2 | 0 |
| Overall Study | Diabetologist nurse in the study | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Didn't return for continuation of study | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Exclusion citeria not met on Visit 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Increased serum creatinine from Baseline | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Liver function test abnormality | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 2 | 1 | 0 | 0 |
| Overall Study | Participant was randomized by mistake | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol violated | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 1 | 1 | 0 | 1 | 1 | 1 |
| Overall Study | Sponsor decided to withdraw participant | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | State ban of biological samples export | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 1 | 5 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Pioglitazone 30 mg | GSK189075 1000 mg | GSK189075 500 mg | GSK189075 250 mg | GSK189075 100 mg | GSK189075 50 mg |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 55.9 Years STANDARD_DEVIATION 9.67 | 54.8 Years STANDARD_DEVIATION 9.16 | 54.5 Years STANDARD_DEVIATION 9.45 | 52.4 Years STANDARD_DEVIATION 9.03 | 54.6 Years STANDARD_DEVIATION 9.33 | 55.7 Years STANDARD_DEVIATION 9.46 | 56.0 Years STANDARD_DEVIATION 8.11 | 54.3 Years STANDARD_DEVIATION 9.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 19 Participants | 4 Participants | 3 Participants | 0 Participants | 3 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 13 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 16 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 41 Participants | 276 Participants | 39 Participants | 40 Participants | 42 Participants | 41 Participants | 36 Participants | 37 Participants |
| Sex: Female, Male Female | 18 Participants | 141 Participants | 24 Participants | 20 Participants | 20 Participants | 19 Participants | 17 Participants | 23 Participants |
| Sex: Female, Male Male | 30 Participants | 193 Participants | 24 Participants | 27 Participants | 28 Participants | 29 Participants | 31 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 47 | 0 / 48 | 0 / 48 | 0 / 48 | 0 / 47 | 0 / 48 |
| other Total, other adverse events | 3 / 48 | 5 / 47 | 5 / 48 | 4 / 48 | 5 / 48 | 3 / 47 | 12 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 47 | 0 / 48 | 0 / 48 | 0 / 48 | 0 / 47 | 0 / 48 |
Outcome results
Primary
Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12
Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Only those participants with a value at Baseline and at Week 12 (after Last Observation Carried Forward \[LOCF\]) were used for this analysis. Adjusted mean is presented as least square mean.
Time frame: Baseline (Week 0) and Week 12
Population: Intent to Treat (ITT) Population with LOCF comprised of all randomized participants who received at least one dose of randomized study medication, had a Baseline assessment and had at least one corresponding on-therapy (scheduled or unscheduled) efficacy assessment. One extreme outlier participant had withdrawn from Placebo arm (lack of efficacy).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | -0.31 Percentage of hemoglobin | Standard Error 0.107 |
| GSK189075 50 mg | Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | -1.04 Percentage of hemoglobin | Standard Error 0.105 |
| GSK189075 100 mg | Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | -0.96 Percentage of hemoglobin | Standard Error 0.107 |
| GSK189075 250 mg | Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | -1.05 Percentage of hemoglobin | Standard Error 0.106 |
| GSK189075 500 mg | Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | -1.21 Percentage of hemoglobin | Standard Error 0.102 |
| GSK189075 1000 mg | Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | -1.38 Percentage of hemoglobin | Standard Error 0.104 |
| Pioglitazone 30 mg | Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 | -1.07 Percentage of hemoglobin | Standard Error 0.102 |
Comparison: Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg, GSK189075 1000 mgp-value: <0.001ANCOVA
Comparison: Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mgp-value: <0.001ANCOVA
Comparison: Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mgp-value: <0.001ANCOVA
Comparison: Placebo, GSK189075 50 mg, GSK189075 100 mgp-value: <0.001ANCOVA
Comparison: Placebo, GSK189075 50 mgp-value: <0.001ANCOVA
Comparison: Placebo vs. GSK189075 50 mgp-value: <0.00195% CI: [-1.02, -0.44]ANCOVA
Comparison: Placebo vs. GSK189075 100 mgp-value: <0.00195% CI: [-0.94, -0.35]ANCOVA
Comparison: Placebo vs. GSK189075 250 mgp-value: <0.00195% CI: [-1.03, -0.44]ANCOVA
Comparison: Placebo vs. GSK189075 500 mgp-value: <0.00195% CI: [-1.19, -0.61]ANCOVA
Comparison: Placebo vs. GSK189075 1000 mgp-value: <0.00195% CI: [-1.36, -0.77]ANCOVA
Comparison: Placebo vs. Pioglitazone 30 mgp-value: <0.00195% CI: [-1.05, -0.47]ANCOVA
Secondary
Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine
A 24-hour urine collection was obtained from all participants at Baseline (Week 0) and Week 12 to measure glucose. Participants were provided with urine collection bottles and cooler prior to these visits and instructed that the urine collections must be kept cold and dropped off at the clinic prior to or at the scheduled visits. Site staff queried participants to determine whether the sample represented a full 24-hour collection. The total volume and the sample date and time were recorded. The entire 24-hour urine collection was well mixed in one container and a urine aliquot obtained. Samples were assayed for glucose. The 24-hour collections were used to derive 24-hour urine glucose excretion corrected for filtered load. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) and Week 12 (24-hour urine collection)
Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | -1.09 Percentage of filtered glucose molecules | Standard Deviation 5.731 |
| GSK189075 50 mg | Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | 27.96 Percentage of filtered glucose molecules | Standard Deviation 15.693 |
| GSK189075 100 mg | Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | 40.43 Percentage of filtered glucose molecules | Standard Deviation 16.144 |
| GSK189075 250 mg | Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | 38.98 Percentage of filtered glucose molecules | Standard Deviation 19.006 |
| GSK189075 500 mg | Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | 42.41 Percentage of filtered glucose molecules | Standard Deviation 22.708 |
| GSK189075 1000 mg | Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | 52.39 Percentage of filtered glucose molecules | Standard Deviation 15.264 |
| Pioglitazone 30 mg | Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine | -0.99 Percentage of filtered glucose molecules | Standard Deviation 2.313 |
Secondary
Change From Baseline in C-peptide AUC During a 2-hr OGTT
Post-prandial assessments of C-peptide were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)
Population: OGTT with LOCF Population. Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-peptide AUC During a 2-hr OGTT | -0.140 Nanomol*hour per Liter (nmol*hr/L) | Standard Deviation 0.7348 |
| GSK189075 50 mg | Change From Baseline in C-peptide AUC During a 2-hr OGTT | 0.654 Nanomol*hour per Liter (nmol*hr/L) | Standard Deviation 1.4023 |
| GSK189075 100 mg | Change From Baseline in C-peptide AUC During a 2-hr OGTT | -0.156 Nanomol*hour per Liter (nmol*hr/L) | Standard Deviation 1.0566 |
| GSK189075 250 mg | Change From Baseline in C-peptide AUC During a 2-hr OGTT | -0.026 Nanomol*hour per Liter (nmol*hr/L) | Standard Deviation 0.9606 |
| GSK189075 500 mg | Change From Baseline in C-peptide AUC During a 2-hr OGTT | -0.476 Nanomol*hour per Liter (nmol*hr/L) | Standard Deviation 0.4668 |
| GSK189075 1000 mg | Change From Baseline in C-peptide AUC During a 2-hr OGTT | -0.175 Nanomol*hour per Liter (nmol*hr/L) | Standard Deviation 0.8322 |
| Pioglitazone 30 mg | Change From Baseline in C-peptide AUC During a 2-hr OGTT | -0.239 Nanomol*hour per Liter (nmol*hr/L) | Standard Deviation 0.6732 |
Secondary
Change From Baseline in HbA1c (%) at Weeks 4 and 8
Fasted blood samples for HbA1c were collected at Baseline and Weeks 4 and 8. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) and Week 4 and Week 8
Population: ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis. One extreme outlier participant had withdrawn from Placebo arm due to lack of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 4 | -0.30 Percentage of hemoglobin | Standard Deviation 0.535 |
| Placebo | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 8 | -0.41 Percentage of hemoglobin | Standard Deviation 0.689 |
| GSK189075 50 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 4 | -0.77 Percentage of hemoglobin | Standard Deviation 0.541 |
| GSK189075 50 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 8 | -0.98 Percentage of hemoglobin | Standard Deviation 0.712 |
| GSK189075 100 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 4 | -0.69 Percentage of hemoglobin | Standard Deviation 0.583 |
| GSK189075 100 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 8 | -0.96 Percentage of hemoglobin | Standard Deviation 0.827 |
| GSK189075 250 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 4 | -0.64 Percentage of hemoglobin | Standard Deviation 0.535 |
| GSK189075 250 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 8 | -0.99 Percentage of hemoglobin | Standard Deviation 0.751 |
| GSK189075 500 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 4 | -0.83 Percentage of hemoglobin | Standard Deviation 0.639 |
| GSK189075 500 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 8 | -1.07 Percentage of hemoglobin | Standard Deviation 0.747 |
| GSK189075 1000 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 4 | -0.84 Percentage of hemoglobin | Standard Deviation 0.551 |
| GSK189075 1000 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 8 | -1.28 Percentage of hemoglobin | Standard Deviation 0.636 |
| Pioglitazone 30 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 4 | -0.39 Percentage of hemoglobin | Standard Deviation 0.557 |
| Pioglitazone 30 mg | Change From Baseline in HbA1c (%) at Weeks 4 and 8 | Week 8 | -0.88 Percentage of hemoglobin | Standard Deviation 0.713 |
Secondary
Change From Baseline in Insulin AUC During a 2-hour OGTT
Post-prandial assessments of insulin were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) and Week 12 (0 to 2-hour OGTT)
Population: OGTT with LOCF Population. Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Insulin AUC During a 2-hour OGTT | -5.3 Picomol*hour per Liter (pmol*hr/L) | Standard Deviation 177.23 |
| GSK189075 50 mg | Change From Baseline in Insulin AUC During a 2-hour OGTT | 162.4 Picomol*hour per Liter (pmol*hr/L) | Standard Deviation 362.82 |
| GSK189075 100 mg | Change From Baseline in Insulin AUC During a 2-hour OGTT | -70.9 Picomol*hour per Liter (pmol*hr/L) | Standard Deviation 193.77 |
| GSK189075 250 mg | Change From Baseline in Insulin AUC During a 2-hour OGTT | 66.6 Picomol*hour per Liter (pmol*hr/L) | Standard Deviation 213.07 |
| GSK189075 500 mg | Change From Baseline in Insulin AUC During a 2-hour OGTT | -173.9 Picomol*hour per Liter (pmol*hr/L) | Standard Deviation 143.52 |
| GSK189075 1000 mg | Change From Baseline in Insulin AUC During a 2-hour OGTT | -97.8 Picomol*hour per Liter (pmol*hr/L) | Standard Deviation 224.24 |
| Pioglitazone 30 mg | Change From Baseline in Insulin AUC During a 2-hour OGTT | 10.0 Picomol*hour per Liter (pmol*hr/L) | Standard Deviation 128.77 |
Secondary
Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT)
Post-prandial assessments of glucose were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)
Population: The OGTT Population with LOCF which comprised of participants in the ITT population having evaluable Baseline and corresponding on-therapy OGTT measurements (for at least one of the measured parameters of FPG, C-Peptide or Insulin). Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | -0.90 Millimol*hour per Liter (mmol*hr/L) | Standard Deviation 5.739 |
| GSK189075 50 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | -6.31 Millimol*hour per Liter (mmol*hr/L) | Standard Deviation 5.907 |
| GSK189075 100 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | -6.71 Millimol*hour per Liter (mmol*hr/L) | Standard Deviation 7.326 |
| GSK189075 250 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | -7.69 Millimol*hour per Liter (mmol*hr/L) | Standard Deviation 3.791 |
| GSK189075 500 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | -6.06 Millimol*hour per Liter (mmol*hr/L) | Standard Deviation 2.837 |
| GSK189075 1000 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | -7.59 Millimol*hour per Liter (mmol*hr/L) | Standard Deviation 3.065 |
| Pioglitazone 30 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) | -6.55 Millimol*hour per Liter (mmol*hr/L) | Standard Deviation 3.841 |
Secondary
Change From Baseline to Week 12 in Body Weight
Weight of participants was measured from Baseline (Week 0) to Week 12 and recorded in the case report form (CRF). Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) to Week 12
Population: ITT population with LOCF for withdrawn participants or missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Body Weight | -0.49 Kilograms | Standard Deviation 1.719 |
| GSK189075 50 mg | Change From Baseline to Week 12 in Body Weight | -1.78 Kilograms | Standard Deviation 3.197 |
| GSK189075 100 mg | Change From Baseline to Week 12 in Body Weight | -2.41 Kilograms | Standard Deviation 2.85 |
| GSK189075 250 mg | Change From Baseline to Week 12 in Body Weight | -2.38 Kilograms | Standard Deviation 2.875 |
| GSK189075 500 mg | Change From Baseline to Week 12 in Body Weight | -3.52 Kilograms | Standard Deviation 2.874 |
| GSK189075 1000 mg | Change From Baseline to Week 12 in Body Weight | -4.00 Kilograms | Standard Deviation 2.945 |
| Pioglitazone 30 mg | Change From Baseline to Week 12 in Body Weight | 0.96 Kilograms | Standard Deviation 2.425 |
Secondary
Change From Baseline to Week 12 in Fasting Insulin
Fasted blood samples for insulin were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) to Week 12
Population: ITT Population with LOCF. Only those participants with a value at Baseline and up to Week 12 (after LOCF) were used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Fasting Insulin | -30.6 Picomol per Liter (pmol/L) | Standard Deviation 171.35 |
| GSK189075 50 mg | Change From Baseline to Week 12 in Fasting Insulin | 0.3 Picomol per Liter (pmol/L) | Standard Deviation 58.69 |
| GSK189075 100 mg | Change From Baseline to Week 12 in Fasting Insulin | -20.7 Picomol per Liter (pmol/L) | Standard Deviation 60.75 |
| GSK189075 250 mg | Change From Baseline to Week 12 in Fasting Insulin | -9.7 Picomol per Liter (pmol/L) | Standard Deviation 43.95 |
| GSK189075 500 mg | Change From Baseline to Week 12 in Fasting Insulin | -25.8 Picomol per Liter (pmol/L) | Standard Deviation 60.94 |
| GSK189075 1000 mg | Change From Baseline to Week 12 in Fasting Insulin | -15.1 Picomol per Liter (pmol/L) | Standard Deviation 57.59 |
| Pioglitazone 30 mg | Change From Baseline to Week 12 in Fasting Insulin | -2.1 Picomol per Liter (pmol/L) | Standard Deviation 49.6 |
Secondary
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12
Fasted blood samples for FPG were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) and Week 4, Week 8 and Week 12
Population: ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis. One extreme outlier participant had withdrawn from Placebo arm due to lack of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 12 | -0.51 Millimoles per Liter (mmol/L) | Standard Deviation 1.7 |
| Placebo | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 8 | -0.62 Millimoles per Liter (mmol/L) | Standard Deviation 1.859 |
| Placebo | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 4 | -0.49 Millimoles per Liter (mmol/L) | Standard Deviation 1.991 |
| GSK189075 50 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 8 | -0.91 Millimoles per Liter (mmol/L) | Standard Deviation 2.073 |
| GSK189075 50 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 4 | -0.56 Millimoles per Liter (mmol/L) | Standard Deviation 1.512 |
| GSK189075 50 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 12 | -0.89 Millimoles per Liter (mmol/L) | Standard Deviation 1.96 |
| GSK189075 100 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 12 | -1.63 Millimoles per Liter (mmol/L) | Standard Deviation 2.145 |
| GSK189075 100 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 8 | -1.30 Millimoles per Liter (mmol/L) | Standard Deviation 1.821 |
| GSK189075 100 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 4 | -1.43 Millimoles per Liter (mmol/L) | Standard Deviation 2.005 |
| GSK189075 250 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 12 | -1.80 Millimoles per Liter (mmol/L) | Standard Deviation 2.107 |
| GSK189075 250 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 4 | -1.49 Millimoles per Liter (mmol/L) | Standard Deviation 2.314 |
| GSK189075 250 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 8 | -1.76 Millimoles per Liter (mmol/L) | Standard Deviation 2.137 |
| GSK189075 500 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 8 | -2.14 Millimoles per Liter (mmol/L) | Standard Deviation 2.547 |
| GSK189075 500 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 4 | -1.90 Millimoles per Liter (mmol/L) | Standard Deviation 2.232 |
| GSK189075 500 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 12 | -2.07 Millimoles per Liter (mmol/L) | Standard Deviation 2.459 |
| GSK189075 1000 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 4 | -2.48 Millimoles per Liter (mmol/L) | Standard Deviation 2.491 |
| GSK189075 1000 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 8 | -2.78 Millimoles per Liter (mmol/L) | Standard Deviation 2.531 |
| GSK189075 1000 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 12 | -2.76 Millimoles per Liter (mmol/L) | Standard Deviation 2.821 |
| Pioglitazone 30 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 12 | -1.71 Millimoles per Liter (mmol/L) | Standard Deviation 1.978 |
| Pioglitazone 30 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 8 | -1.73 Millimoles per Liter (mmol/L) | Standard Deviation 1.34 |
| Pioglitazone 30 mg | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 | Week 4 | -1.26 Millimoles per Liter (mmol/L) | Standard Deviation 1.294 |
Secondary
Change From Baseline to Week 12 in Fructosamine
Fasted blood samples for fructosamine were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) to Week 12
Population: ITT Population with LOCF. Only those participants with a value at Baseline up to Week 12 (after LOCF) were used for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Fructosamine | 5.7 Micromol per Liter (mcmol/L) | Standard Deviation 51.24 |
| GSK189075 50 mg | Change From Baseline to Week 12 in Fructosamine | -33.8 Micromol per Liter (mcmol/L) | Standard Deviation 38.2 |
| GSK189075 100 mg | Change From Baseline to Week 12 in Fructosamine | -35.7 Micromol per Liter (mcmol/L) | Standard Deviation 41.69 |
| GSK189075 250 mg | Change From Baseline to Week 12 in Fructosamine | -38.9 Micromol per Liter (mcmol/L) | Standard Deviation 29.62 |
| GSK189075 500 mg | Change From Baseline to Week 12 in Fructosamine | -41.9 Micromol per Liter (mcmol/L) | Standard Deviation 35.54 |
| GSK189075 1000 mg | Change From Baseline to Week 12 in Fructosamine | -55.2 Micromol per Liter (mcmol/L) | Standard Deviation 30.31 |
| Pioglitazone 30 mg | Change From Baseline to Week 12 in Fructosamine | -34.7 Micromol per Liter (mcmol/L) | Standard Deviation 38.84 |
Secondary
Change From Baseline to Week 12 in Waist Circumference
Waist circumference of participants was measured from Baseline (Week 0) to Week 12 and recorded in the CRF. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Baseline (Week 0) to Week 12
Population: ITT population with LOCF for withdrawn participants or missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Waist Circumference | -0.7 Centimeters | Standard Deviation 2.92 |
| GSK189075 50 mg | Change From Baseline to Week 12 in Waist Circumference | -1.2 Centimeters | Standard Deviation 3.58 |
| GSK189075 100 mg | Change From Baseline to Week 12 in Waist Circumference | -2.0 Centimeters | Standard Deviation 4.51 |
| GSK189075 250 mg | Change From Baseline to Week 12 in Waist Circumference | -2.2 Centimeters | Standard Deviation 3.43 |
| GSK189075 500 mg | Change From Baseline to Week 12 in Waist Circumference | -2.6 Centimeters | Standard Deviation 3.31 |
| GSK189075 1000 mg | Change From Baseline to Week 12 in Waist Circumference | -2.4 Centimeters | Standard Deviation 4.26 |
| Pioglitazone 30 mg | Change From Baseline to Week 12 in Waist Circumference | 1.3 Centimeters | Standard Deviation 4.82 |
Secondary
Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L
Fasted blood samples for HbA1c were collected at Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Number of participants at Week 12 with: HbA1c \<= 6.5%, HbA1c \<7.0%; FPG \<7 mmo/L (126 milligram/deciliter \[mg/dL\]), FPG \<7.8 mmol/L (140 mg/dL); FPG \<5.5 mmol/L (100 mg/dL); a decrease from Baseline of HbA1c \>= 0.7%; a decrease from Baseline of FPG ≥1.7 mmol/L (30 mg/dL) are presented.
Time frame: Week 12
Population: ITT Population with Last Observation Carried Forward (LOCF). Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of HbA1c >= 0.7% | 16 Participants |
| Placebo | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <5.5 mmol/L | 0 Participants |
| Placebo | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7 mmo/L | 4 Participants |
| Placebo | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <7.0% | 9 Participants |
| Placebo | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7.8 mmol/L | 13 Participants |
| Placebo | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <= 6.5% | 3 Participants |
| Placebo | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of FPG ≥1.7 mmol/L | 8 Participants |
| GSK189075 50 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <7.0% | 20 Participants |
| GSK189075 50 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7 mmo/L | 16 Participants |
| GSK189075 50 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7.8 mmol/L | 24 Participants |
| GSK189075 50 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <= 6.5% | 10 Participants |
| GSK189075 50 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of HbA1c >= 0.7% | 33 Participants |
| GSK189075 50 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of FPG ≥1.7 mmol/L | 15 Participants |
| GSK189075 50 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <5.5 mmol/L | 4 Participants |
| GSK189075 100 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <7.0% | 18 Participants |
| GSK189075 100 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7 mmo/L | 20 Participants |
| GSK189075 100 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of FPG ≥1.7 mmol/L | 19 Participants |
| GSK189075 100 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of HbA1c >= 0.7% | 27 Participants |
| GSK189075 100 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7.8 mmol/L | 26 Participants |
| GSK189075 100 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <5.5 mmol/L | 2 Participants |
| GSK189075 100 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <= 6.5% | 8 Participants |
| GSK189075 250 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of HbA1c >= 0.7% | 33 Participants |
| GSK189075 250 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7 mmo/L | 18 Participants |
| GSK189075 250 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7.8 mmol/L | 27 Participants |
| GSK189075 250 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <5.5 mmol/L | 5 Participants |
| GSK189075 250 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of FPG ≥1.7 mmol/L | 21 Participants |
| GSK189075 250 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <= 6.5% | 11 Participants |
| GSK189075 250 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <7.0% | 22 Participants |
| GSK189075 500 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <7.0% | 28 Participants |
| GSK189075 500 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7.8 mmol/L | 33 Participants |
| GSK189075 500 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of HbA1c >= 0.7% | 36 Participants |
| GSK189075 500 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <= 6.5% | 17 Participants |
| GSK189075 500 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7 mmo/L | 22 Participants |
| GSK189075 500 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of FPG ≥1.7 mmol/L | 24 Participants |
| GSK189075 500 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <5.5 mmol/L | 4 Participants |
| GSK189075 1000 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <5.5 mmol/L | 3 Participants |
| GSK189075 1000 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of FPG ≥1.7 mmol/L | 30 Participants |
| GSK189075 1000 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of HbA1c >= 0.7% | 39 Participants |
| GSK189075 1000 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7.8 mmol/L | 34 Participants |
| GSK189075 1000 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <7.0% | 29 Participants |
| GSK189075 1000 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <= 6.5% | 17 Participants |
| GSK189075 1000 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7 mmo/L | 22 Participants |
| Pioglitazone 30 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of HbA1c >= 0.7% | 28 Participants |
| Pioglitazone 30 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | Decrease from Baseline of FPG ≥1.7 mmol/L | 23 Participants |
| Pioglitazone 30 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7.8 mmol/L | 31 Participants |
| Pioglitazone 30 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <7.0% | 21 Participants |
| Pioglitazone 30 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | HbA1c <= 6.5% | 8 Participants |
| Pioglitazone 30 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <7 mmo/L | 21 Participants |
| Pioglitazone 30 mg | Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L | FPG <5.5 mmol/L | 2 Participants |
Secondary
Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern
Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. An additional fasting blood sample (serum and plasma) was drawn at Week 0, Week 4, Week 6 and Week 12 or at early withdrawal (up to 14 weeks) and kept in long-term storage for future testing of biomarkers for diabetes and complications of the disease. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Up to 14 weeks
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hemoglobin | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hematocrit | 1 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hemoglobin | 0 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hematocrit | 0 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hemoglobin | 0 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hematocrit | 0 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hemoglobin | 0 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hematocrit | 0 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hemoglobin | 0 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hematocrit | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hemoglobin | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hematocrit | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hemoglobin | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern | Low Hematocrit | 0 Participants |
Secondary
Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern
Vital signs included heart rate and blood pressure. Heart rate and blood pressure were taken before blood draws were performed. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. Heart rate and blood pressure was measured pre-dose in duplicate at the specified visits, after the participant had been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Heart rate was measured at the same time as blood pressure using the standardized blood pressure equipment that was provided. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time frame: Up to 14 weeks
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low heart rate | 0 Participants |
| Placebo | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low SBP | 0 Participants |
| Placebo | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low DBP | 0 Participants |
| Placebo | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High SBP | 3 Participants |
| Placebo | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High DBP | 1 Participants |
| Placebo | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High heart rate | 0 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High SBP | 0 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low DBP | 1 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low heart rate | 0 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low SBP | 0 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High heart rate | 1 Participants |
| GSK189075 50 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High DBP | 0 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High heart rate | 0 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High DBP | 0 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low heart rate | 0 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low DBP | 2 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High SBP | 2 Participants |
| GSK189075 100 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low SBP | 1 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High heart rate | 0 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High SBP | 0 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low SBP | 2 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High DBP | 0 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low DBP | 0 Participants |
| GSK189075 250 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low heart rate | 0 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low DBP | 0 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low SBP | 2 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High heart rate | 0 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low heart rate | 1 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High DBP | 0 Participants |
| GSK189075 500 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High SBP | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High DBP | 2 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low DBP | 1 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low SBP | 2 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High heart rate | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High SBP | 1 Participants |
| GSK189075 1000 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low heart rate | 1 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High DBP | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low SBP | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low heart rate | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | Low DBP | 3 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High heart rate | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern | High SBP | 0 Participants |
Secondary
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
Full 12-lead ECGs were recorded at screening, Baseline (Week 0), Week 4, Week 12 or early withdrawal, and Week 14 (Follow-up) using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was \>500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was \>500 msec, the participant was withdrawn from the study.
Time frame: Up to Early withdrawal (Between Week 12 and Week 14)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QRS Duration > 200 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Bazett) > 500 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | PR interval > 300 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Fridericia) > 500 msec | 0 Participants |
| GSK189075 50 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QRS Duration > 200 msec | 0 Participants |
| GSK189075 50 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Fridericia) > 500 msec | 0 Participants |
| GSK189075 50 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | PR interval > 300 msec | 0 Participants |
| GSK189075 50 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Bazett) > 500 msec | 0 Participants |
| GSK189075 100 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Fridericia) > 500 msec | 0 Participants |
| GSK189075 100 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | PR interval > 300 msec | 0 Participants |
| GSK189075 100 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Bazett) > 500 msec | 0 Participants |
| GSK189075 100 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QRS Duration > 200 msec | 0 Participants |
| GSK189075 250 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Fridericia) > 500 msec | 0 Participants |
| GSK189075 250 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QRS Duration > 200 msec | 0 Participants |
| GSK189075 250 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | PR interval > 300 msec | 0 Participants |
| GSK189075 250 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Bazett) > 500 msec | 0 Participants |
| GSK189075 500 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QRS Duration > 200 msec | 0 Participants |
| GSK189075 500 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | PR interval > 300 msec | 0 Participants |
| GSK189075 500 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Bazett) > 500 msec | 0 Participants |
| GSK189075 500 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Fridericia) > 500 msec | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Fridericia) > 500 msec | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QRS Duration > 200 msec | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | PR interval > 300 msec | 0 Participants |
| GSK189075 1000 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Bazett) > 500 msec | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Bazett) > 500 msec | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QTc(Fridericia) > 500 msec | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | PR interval > 300 msec | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | QRS Duration > 200 msec | 0 Participants |
Secondary
Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE)
AE is 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. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is 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, or is a congenital anomaly/birth defect or is medically significant.
Time frame: Up to 12 weeks
Population: Safety population which comprised of all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| Placebo | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 18 Participants |
| GSK189075 50 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| GSK189075 50 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 18 Participants |
| GSK189075 100 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 17 Participants |
| GSK189075 100 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| GSK189075 250 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 19 Participants |
| GSK189075 250 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| GSK189075 500 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 18 Participants |
| GSK189075 500 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| GSK189075 1000 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 22 Participants |
| GSK189075 1000 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 22 Participants |
| Pioglitazone 30 mg | Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
Secondary
Number of Participants With On-therapy Hypoglycemia
Hypoglycemia is low blood glucose or low blood sugar. Hypoglycemic events were collected separately and reported separately from AE, including supplemental data which were not collected for AE. However, any hypoglycemic event which met the criteria for a SAE was included in the SAE summaries. The number of participants in each group that experienced a hypoglycemic event was summarized by frequency of the events.
Time frame: Up to 14 weeks
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With On-therapy Hypoglycemia | 1 Participants |
| GSK189075 50 mg | Number of Participants With On-therapy Hypoglycemia | 1 Participants |
| GSK189075 100 mg | Number of Participants With On-therapy Hypoglycemia | 0 Participants |
| GSK189075 250 mg | Number of Participants With On-therapy Hypoglycemia | 0 Participants |
| GSK189075 500 mg | Number of Participants With On-therapy Hypoglycemia | 1 Participants |
| GSK189075 1000 mg | Number of Participants With On-therapy Hypoglycemia | 0 Participants |
| Pioglitazone 30 mg | Number of Participants With On-therapy Hypoglycemia | 0 Participants |
Secondary
Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C])
Fasted samples for TC, LDL-C, HDL-C and TG were collected at Week 12. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent Change based on log-transformed data: 100\*(exponentiated(mean change on log scale)-1)
Time frame: Baseline (Week 0) and Week 4, Week 8 and Week 12
Population: ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 12 | 4.75 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 8 | 3.17 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 4 | 0.82 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 12 | 0.00 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 8 | -1.66 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 12 | 3.32 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 8 | 0.00 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 4 | 0.47 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 4 | -8.35 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 4 | -1.97 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 8 | 0.82 Percent change |
| Placebo | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 12 | 3.17 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 8 | 8.67 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 8 | 6.20 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 8 | 3.49 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 12 | -10.91 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 4 | 5.43 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 4 | 1.85 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 12 | 3.39 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 12 | 5.56 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 4 | 0.83 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 12 | 6.69 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 8 | -9.09 Percent change |
| GSK189075 50 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 4 | -3.45 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 12 | 3.57 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 12 | 5.45 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 8 | 0.59 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 8 | 3.62 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 12 | 10.92 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 4 | 6.32 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 8 | 3.64 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 4 | 3.69 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 4 | 0.37 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 12 | 4.96 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 8 | 5.00 Percent change |
| GSK189075 100 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 4 | 1.62 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 8 | 3.09 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 4 | -13.42 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 8 | -10.01 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 12 | -4.71 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 4 | 4.13 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 8 | 4.49 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 12 | 3.97 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 4 | 6.91 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 8 | 8.96 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 12 | 3.93 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 4 | 5.13 Percent change |
| GSK189075 250 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 12 | 6.70 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 12 | 11.43 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 4 | -13.04 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 12 | -15.28 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 4 | 4.43 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 4 | 5.69 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 8 | 7.57 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 4 | 10.03 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 8 | 7.14 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 8 | 5.31 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 8 | -13.35 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 12 | 9.82 Percent change |
| GSK189075 500 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 12 | 11.93 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 4 | 7.02 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 8 | 0.00 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 8 | 4.44 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 4 | 2.39 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 12 | 14.89 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 12 | -9.97 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 12 | 4.27 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 4 | 0.00 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 8 | -7.30 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 8 | 0.00 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 4 | -4.62 Percent change |
| GSK189075 1000 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 12 | 2.77 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 4 | 0.00 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 4 | 2.29 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 8 | -2.24 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 12 | 10.00 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 8 | 8.20 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 4 | -7.22 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 8 | 1.06 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 12 | -7.19 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TC: Week 12 | -2.05 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | HDL-C: Week 4 | 9.18 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | LDL-C: Week 12 | 1.18 Percent change |
| Pioglitazone 30 mg | Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) | TG: Week 8 | -0.79 Percent change |