Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK189075 | Experimental | Participants will receive GSK189075 for 12 weeks |
|
| Placebo | Placebo Comparator | Participants will receive GSK189075 matching Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK189075 | Drug | GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12 | The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean. | Baseline (Week 0) and at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in HbA1c at Weeks 4 and 8 | The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. |
Not provided
Inclusion Criteria:
Subjects with a documented diagnosis of T2DM and HbA1c ≥7.0% and ≤9.5% measured by the central laboratory at Visit 1.
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 childbearing and non-childbearing and potential are eligible to participate as follows:
All females must have a negative urine pregnancy test on the day of, and prior to randomization.
Exclusion Criteria:
Metabolic Disease
Diabetic Medication
Cardiovascular Disease
Recent history or presence of clinically significant acute cardiovascular disease including:
Documented myocardial infarction in the 6 months prior to Screening.
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.
Unstable angina in the 6 months prior to Screening.
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.
Congestive heart failure (CHF, New York Heart Association (NYHA) Class II to IV) requiring pharmacologic treatment or the NYHA Class criteria in accordance with the local prescribing information for pioglitazone.
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.
Based on local readings, the subject has an initial QTc interval (Bazett's)≥450msec at Screening, and after two additional ECGs taken 5 minutes apart, the average of the QTC interval from the three ECGs is ≥450msec.
Other clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of efficacy or 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.
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 aminotransferase (ALT)
aspartate aminotransferase (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.
Secondary causes of diabetes:
history of chronic or acute pancreatitis
Significant renal disease at Screening as manifested by:
Glomerular filtration rate (GFR) <60mL/min (as calculated by Quest at Visit using the Modification of Diet in Renal Disease (MDRD) equation
•≥1+ protein on urine dipstick
Trace or ≥1+ leukocyte esterase on urine dipstick
Trace or ≥1+ blood on urine dipstick
Positive nitrite on urine dipstick
Recurrent genitourinary tract infections defined as ≥2 episodes of complicated or uncomplicated cystitis or pyelonephritis in the 6 months prior to Screening.
Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests (including blood electrolytes), ECG, 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.).
History of malignancy within the past 5 years other than superficial squamous cell carcinoma (non-invasive on pathology) or basal cell carcinoma (successfully treated with local excision).
History of cervical cancer in situ treated definitively at least 6 months prior to Screening.
Is currently taking or has taken any of the following medications in the 8 weeks prior to Screening:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mesa | Arizona | 85206 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25238025 | Derived | Sykes AP, Kemp GL, Dobbins R, O'Connor-Semmes R, Almond SR, Wilkison WO, Walker S, Kler L. Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):98-101. doi: 10.1111/dom.12393. Epub 2014 Nov 3. |
Not provided
Not provided
A total of 822 participants with Type 2 Diabetes Mellitus who were treatment naïve, entered the 2-week screening period. Of these, 570 were screen failures. The primary reason for screening failure was the participant not meeting eligibility criteria. Out of 252 randomized participants, 250 participants received study drug.
The study was conducted at 130 centers in 14 countries (9 European, 3 International countries, Canada, and the United States) during the period from 17 August 2007 to 5 June 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 2 placebo tablets matching for GSK189075 twice daily (BID) before breakfast and dinner and 1 placebo capsule matching for Pioglitazone once daily (QD) before breakfast for 12 weeks |
| FG001 | GSK189075 100 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Available as Placebo matching tablet to GSK189075 |
|
| Baseline (Week 0) and at Week 4 nad 8 |
| Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) | The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean. | Baseline (Week 0) and at Week 12 |
| Mean Change From Baseline to Week 12 in Fructosamine (Corrected) | The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean. | Baseline (Week 0) and at Week 12 |
| Number of Participants Who Were HbA1c Responders at Week 12 | Differences between treatment groups in the proportion of participants who achieved HbA1c targets of <=6.5% and <7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (>=0.7%) at Week 12 were assessed in the same manner. | Week 12 |
| Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12 | Differences between treatment groups in the proportion of participants who achieved FPG targets of <7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter [mg/dL]) and <7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of <5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L [>=30 mg/dL]) at Week 12 were assessed in the same manner. | Week 12 |
| Mean Change From Baseline to Week 12 in Triglycerides | Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | Baseline (Week 0) and at Week 12 |
| Mean Change From Baseline to Week 12 in Total Cholesterol | Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | Baseline (Week 0) and at Week 12 |
| Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c) | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | Baseline (Week 0) and Week 12 |
| Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c) | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | Baseline (Week 0) and Week 12 |
| Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | Baseline (Week 0) and Week 12 |
| Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | Baseline (Week 0) and Week 12 |
| Mean Change From Baseline to Week 12 in Body Weight | Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | Baseline (Week 0) and Week 12 |
| Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Up to Week 12 |
| Number of Participants With On-therapy Hypoglycemia | Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia. | Up to Week 12 |
| Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy | Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. | Up to Week 12 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline | Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was >500 milliseconds 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 milliseconds, the participant was withdrawn from the study. | Up to Week 12 |
| Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy | Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). | Up to Week 12 |
| Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy | Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). | Up to Week 12 |
| Artesia |
| California |
| 90701 |
| United States |
| GSK Investigational Site | Buena Park | California | 90620 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Greenbrae | California | 94904 | United States |
| GSK Investigational Site | La Jolla | California | 92037 | United States |
| GSK Investigational Site | Norwalk | California | 90650 | United States |
| GSK Investigational Site | Petaluma | California | 94954 | United States |
| GSK Investigational Site | Sacramento | California | 95823 | United States |
| GSK Investigational Site | San Mateo | California | 94401 | United States |
| GSK Investigational Site | Santa Ana | California | 92701 | United States |
| GSK Investigational Site | Tarzana | California | 91356 | United States |
| GSK Investigational Site | Torrance | California | 90505 | United States |
| GSK Investigational Site | Deland/Florida | Florida | 32720 | United States |
| GSK Investigational Site | Hollywood | Florida | 33023 | United States |
| GSK Investigational Site | Jacksonville/Florida | Florida | 32223 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | Miami | Florida | 33169 | United States |
| GSK Investigational Site | Ocoee/Florida | Florida | 34761 | United States |
| GSK Investigational Site | Saint Cloud | Florida | 34769 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30322 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Bloomingdale | Illinois | 60108 | United States |
| GSK Investigational Site | Chicago | Illinois | 60616 | United States |
| GSK Investigational Site | Oak Brook | Illinois | 60523 | United States |
| GSK Investigational Site | South Bend | Indiana | 46614 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70503 | United States |
| GSK Investigational Site | Lake Charles | Louisiana | 70601 | United States |
| GSK Investigational Site | Oxon Hill | Maryland | 20745 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02118 | United States |
| GSK Investigational Site | Gulfport | Mississippi | 39501 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Kosciusko | Mississippi | 39090 | United States |
| GSK Investigational Site | Rolling Fork | Mississippi | 39159 | United States |
| GSK Investigational Site | Chesterfield | Missouri | 63017 | United States |
| GSK Investigational Site | Saint Louis/Missouri | Missouri | 63118 | United States |
| GSK Investigational Site | Henderson | Nevada | 89014 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89016 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89106 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89128 | United States |
| GSK Investigational Site | Clifton | New Jersey | 7011 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| GSK Investigational Site | Commack | New York | 11725 | United States |
| GSK Investigational Site | Ithaca | New York | 14850 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | Asheboro/North Carolina | North Carolina | 27203 | United States |
| GSK Investigational Site | Canal Fulton | Ohio | 44614 | United States |
| GSK Investigational Site | Bensalem/Pennsylvania | Pennsylvania | 19020 | United States |
| GSK Investigational Site | West Chester | Pennsylvania | 19382 | United States |
| GSK Investigational Site | Manning | South Carolina | 29102 | United States |
| GSK Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| GSK Investigational Site | Athens/Tennessee | Tennessee | 37303 | United States |
| GSK Investigational Site | Corpus Christi | Texas | 78404 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Dallas | Texas | 75235 | United States |
| GSK Investigational Site | Harlingen/Texas | Texas | 78550 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Houston | Texas | 77074 | United States |
| GSK Investigational Site | Houston | Texas | 77081 | United States |
| GSK Investigational Site | Midland | Texas | 79705 | United States |
| GSK Investigational Site | San Anonio | Texas | 78221 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Burke | Virginia | 22015 | United States |
| GSK Investigational Site | Bellevue | Washington | 98004 | United States |
| GSK Investigational Site | Langley | British Columbia | V3A 4H9 | Canada |
| GSK Investigational Site | Bathurst | New Brunswick | E2A 4X7 | Canada |
| GSK Investigational Site | Bay Roberts | Newfoundland and Labrador | A0A 1G0 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3T1 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5A 3V4 | Canada |
| GSK Investigational Site | Oakville | Ontario | L6H 3P1 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1K 4K4 | Canada |
| GSK Investigational Site | Thornhill | Ontario | L4J 8L7 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3H 5S4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4R 2G4 | Canada |
| GSK Investigational Site | L'Ancienne-Lorette | Quebec | G2E 2X1 | Canada |
| GSK Investigational Site | Québec | G1V 4G5 | Canada |
| GSK Investigational Site | Brno | 624 00 | Czechia |
| GSK Investigational Site | Brno | 636 00 | Czechia |
| GSK Investigational Site | Prague | 100 00 | Czechia |
| GSK Investigational Site | Prague | 158 00 | Czechia |
| GSK Investigational Site | Pärnu | 80018 | Estonia |
| GSK Investigational Site | Tallinn | 13415 | Estonia |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Allmendingen | Baden-Wurttemberg | 89604 | Germany |
| GSK Investigational Site | Wangen | Baden-Wurttemberg | 88239 | Germany |
| GSK Investigational Site | Großheirath | Bavaria | 96269 | Germany |
| GSK Investigational Site | Hohenau | Bavaria | 94545 | Germany |
| GSK Investigational Site | Künzing | Bavaria | 94550 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80339 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80469 | Germany |
| GSK Investigational Site | Parsberg | Bavaria | 92331 | Germany |
| GSK Investigational Site | Ruhmannsfelden | Bavaria | 94239 | Germany |
| GSK Investigational Site | Sulzbach-Rosenberg | Bavaria | 92237 | Germany |
| GSK Investigational Site | Falkensee | Brandenburg | 14612 | Germany |
| GSK Investigational Site | Brinkum/Stuhr | Lower Saxony | 28816 | Germany |
| GSK Investigational Site | Einbeck | Lower Saxony | 37574 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Lüneburg | Lower Saxony | 21339 | Germany |
| GSK Investigational Site | Tostedt | Lower Saxony | 21255 | Germany |
| GSK Investigational Site | Haßloch | Rhineland-Palatinate | 67454 | Germany |
| GSK Investigational Site | Ingelheim | Rhineland-Palatinate | 55218 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01129 | Germany |
| GSK Investigational Site | Freital | Saxony | 01705 | Germany |
| GSK Investigational Site | Schmiedeberg | Saxony | 01762 | Germany |
| GSK Investigational Site | Wolmirstedt | Saxony-Anhalt | 39326 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23568 | Germany |
| GSK Investigational Site | Berlin | 10115 | Germany |
| GSK Investigational Site | Berlin | 10249 | Germany |
| GSK Investigational Site | Berlin | 12524 | Germany |
| GSK Investigational Site | Berlin | 13347 | Germany |
| GSK Investigational Site | Athens | 115 27 | Greece |
| GSK Investigational Site | Athens | 11528 | Greece |
| GSK Investigational Site | Thessaloniki | 564 29 | Greece |
| GSK Investigational Site | Thessaloniki | 56429 | Greece |
| GSK Investigational Site | Bangalore | 560034 | India |
| GSK Investigational Site | Bangalore | 560043 | India |
| GSK Investigational Site | Chennai | 600010 | India |
| GSK Investigational Site | Mumbai | 400007 | India |
| GSK Investigational Site | Pune | 411004 | India |
| GSK Investigational Site | Kaunas | LT-48259 | Lithuania |
| GSK Investigational Site | Kaunas | LT-50009 | Lithuania |
| GSK Investigational Site | Kaunas | LT-51270 | Lithuania |
| GSK Investigational Site | Vilnius | LT-08661 | Lithuania |
| GSK Investigational Site | Guadalajara | Jalisco | 44150 | Mexico |
| GSK Investigational Site | Cuernavaca | Morelos | 62250 | Mexico |
| GSK Investigational Site | Mérida | Yucatán | 97129 | Mexico |
| GSK Investigational Site | Durango | 34070 | Mexico |
| GSK Investigational Site | Rotorua | 3201 | New Zealand |
| GSK Investigational Site | Bydgoszcz | 85-021 | Poland |
| GSK Investigational Site | PorÄ…bka | 43-353 | Poland |
| GSK Investigational Site | Siemianowice ÅšlÄ…skie | 41-103 | Poland |
| GSK Investigational Site | Wroclaw | 50-349 | Poland |
| GSK Investigational Site | Aibonito/Puerto Rico | Puerto Rico | 00705 | Puerto Rico |
| GSK Investigational Site | Trujillo Alto/Puerto Rico | Puerto Rico | 00976 | Puerto Rico |
| GSK Investigational Site | Caguas | 00725 | Puerto Rico |
| GSK Investigational Site | Carolina | 00983 | Puerto Rico |
| GSK Investigational Site | Ponce | 00717 | Puerto Rico |
| GSK Investigational Site | Rio Piedras | 00921 | Puerto Rico |
| GSK Investigational Site | Arad | 310011 | Romania |
| GSK Investigational Site | Brasov | 500365 | Romania |
| GSK Investigational Site | Sfantu Gheorghe | 520064 | Romania |
| GSK Investigational Site | Timișoara | 300736 | Romania |
| GSK Investigational Site | Moscow | 129110 | Russia |
| GSK Investigational Site | Saint Petersburg | 191025 | Russia |
| GSK Investigational Site | Saint-Peterburgh | 197022 | Russia |
| GSK Investigational Site | Tomsk | 634 050 | Russia |
| GSK Investigational Site | Tyumen | 625023 | Russia |
| GSK Investigational Site | Lenasia South | Gauteng | 01827 | South Africa |
| GSK Investigational Site | Bellville | 7530 | South Africa |
| GSK Investigational Site | Gauteng | 1459 | South Africa |
| GSK Investigational Site | Parow | 7505 | South Africa |
| GSK Investigational Site | Roodepoort | 1709 | South Africa |
| GSK Investigational Site | Dnipropetrovsk | 49027 | Ukraine |
| GSK Investigational Site | Kyiv | 02091 | Ukraine |
| GSK Investigational Site | Vinnitsa | 21010 | Ukraine |
Participants received 2 tablets of GSK189075 50 milligrams (mg) each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| FG002 | GSK189075 250 mg QD | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| FG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| FG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| FG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| FG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks |
| BG001 | GSK189075 100 mg QD | Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| BG002 | GSK189075 250 mg QD | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| BG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| BG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| BG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| BG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12 | The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean. | ITT Population consisted of all randomized participants who received at least one dose of study medication, had a Baseline assessment, and had at least one corresponding on-therapy efficacy assessment. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage | Baseline (Week 0) and at Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in HbA1c at Weeks 4 and 8 | The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percentage | Baseline (Week 0) and at Week 4 nad 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) | The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline (Week 0) and at Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in Fructosamine (Corrected) | The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | micromoles per liter (µmol/L) | Baseline (Week 0) and at Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Were HbA1c Responders at Week 12 | Differences between treatment groups in the proportion of participants who achieved HbA1c targets of <=6.5% and <7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (>=0.7%) at Week 12 were assessed in the same manner. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12 | Differences between treatment groups in the proportion of participants who achieved FPG targets of <7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter [mg/dL]) and <7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of <5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L [>=30 mg/dL]) at Week 12 were assessed in the same manner. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in Triglycerides | Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline (Week 0) and at Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in Total Cholesterol | Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline (Week 0) and at Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c) | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline (Week 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c) | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline (Week 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline (Week 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio | Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline (Week 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to Week 12 in Body Weight | Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean. | ITT Population with LOCF. | Posted | Least Squares Mean | Standard Error | kilograms | Baseline (Week 0) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Safety Population consisted of all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With On-therapy Hypoglycemia | Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia. | Safety Population. | Posted | Count of Participants | Participants | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy | Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline | Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was >500 milliseconds 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 milliseconds, the participant was withdrawn from the study. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy | Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy | Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). | Safety population. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 12 |
|
AEs were reported up to Week 14
Safety Population was used for reporting all AEs
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks. | 0 | 36 | 0 | 36 | 3 | 36 |
| EG001 | GSK189075 100 mg QD | Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. | 0 | 37 | 1 | 37 | 9 | 37 |
| EG002 | GSK189075 250 mg QD | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. | 0 | 34 | 0 | 34 | 11 | 34 |
| EG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. | 0 | 36 | 0 | 36 | 6 | 36 |
| EG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. | 0 | 36 | 0 | 36 | 17 | 36 |
| EG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. | 0 | 36 | 1 | 36 | 7 | 36 |
| EG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. | 0 | 35 | 0 | 35 | 7 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Race |
|
| ANCOVA |
Change=Baseline+Treatment |
| 0.047 |
Tukey's trend test adjusts for multiplicity with statistical significance based on p-value <0.05. |
| Other |
Tukey's trend test for dose response |
| ANCOVA | Change=Baseline+Treatment | 0.006 | Tukey's trend test adjusts for multiplicity with statistical significance based on p-value <0.05. | Other | Tukey's trend test for dose response |
| ANCOVA | Change=Baseline+Treatment | 0.085 | Tukey's trend test adjusts for multiplicity with statistical significance based on p-value <0.05. | Other | Tukey's trend test for dose response |
| ANCOVA | Change=Baseline+Treatment | 0.085 | Pairwise comparison included for informational purposes and not controlled for multiplicity. | Mean Difference (Net) | -0.34 | 2-Sided | 95 | -0.73 | 0.05 | Superiority or Other |
| ANCOVA | Change=Baseline+Treatment | 0.006 | Pairwise comparison included for informational purposes and not controlled for multiplicity | Mean Difference (Net) | -0.56 | 2-Sided | 95 | -0.95 | -0.16 | Superiority or Other |
| ANCOVA | Change=Baseline+Treatment | 0.084 | Pairwise comparison included for informational purposes and not controlled for multiplicity. | Mean Difference (Net) | -0.34 | 2-Sided | 95 | -0.73 | 0.05 | Superiority or Other |
| ANCOVA | Change=Baseline+Treatment | 0.001 | Pairwise comparison included for informational purposes and not controlled for multiplicity. | Mean Difference (Net) | -0.66 | 2-Sided | 95 | -1.05 | -0.28 | Superiority or Other |
| ANCOVA | Change=Baseline+Treatment | 0.003 | Pairwise comparison included for informational purposes and not controlled for multiplicity. | Mean Difference (Net) | -0.59 | 2-Sided | 95 | -0.97 | -0.20 | Superiority or Other |
| ANCOVA | Change=Baseline+Treatment | 0.337 | Pairwise comparison included for informational purposes and not controlled for multiplicity. | Mean Difference (Net) | -0.19 | 2-Sided | 95 | -0.58 | 0.20 | Superiority or Other |
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
| GSK189075 250 mg QD |
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| GSK189075 250 mg QD |
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG002 |
| GSK189075 250 mg QD |
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
| OG003 | GSK189075 500 mg QD | Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG004 | GSK189075 1000 mg QD | Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks. |
| OG005 | GSK189075 250 mg BID | Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks. |
| OG006 | Pioglitazone 30 mg QD | Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks. |
|
|
|
|
|
|
|
|
|