Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00495469 | Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive | PHASE2 | COMPLETED | 250 | — | — | Aug 17, 2007 | Jun 5, 2008 | Oct 30, 2017 | 157 | United States, Canada +14 |
| NCT00500331 | Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM) | PHASE2 | COMPLETED | 334 | — | — | Jan 23, 2007 | Feb 14, 2008 | Dec 6, 2017 | 136 | United States, Argentina +17 |
| NCT00291356 | GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients | PHASE2 | COMPLETED | 45 | — | — | Jan 1, 2006 | May 1, 2006 | Apr 15, 2015 | 3 | United States, Germany |
| NCT00625859 | A Study to Assess the Safety of Repeated Doses of GSK189075 and WELLBUTRIN SR in Healthy Male Subjects | PHASE1 | COMPLETED | 27 | — | — | Jan 16, 2008 | Apr 10, 2008 | Aug 24, 2017 | 1 | United States |
| NCT00519480 | A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin | PHASE1 | COMPLETED | 50 | — | — | Sep 11, 2007 | Apr 1, 2008 | Sep 6, 2017 | 4 | United States, Argentina +1 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| GSK189075 | EXPERIMENTAL | Participants will receive GSK189075 for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Participants will receive GSK189075 matching Placebo for 12 weeks |
| Arm 1 | EXPERIMENTAL | GSK189075 |
| Arm 2 | PLACEBO_COMPARATOR | Placebo |
| Arm 3 | OTHER | pioglitazone (active control) |
| Subjects receiving treatment sequence 1 | EXPERIMENTAL | Eligible subjects will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 2 | EXPERIMENTAL | Eligible subjects will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 3 | EXPERIMENTAL | Eligible subjects will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 4 | EXPERIMENTAL | Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 5 | EXPERIMENTAL | Eligible subjects will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment sequence 6 | EXPERIMENTAL | Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 |
| Subjects receiving treatment P | PLACEBO_COMPARATOR | Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days. |
| Subjects receiving treatment A | EXPERIMENTAL | Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days. |
| Subjects receiving treatment B | EXPERIMENTAL | Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days. |
| Name | Type | Description |
|---|---|---|
| GSK189075 | DRUG | GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet |
| Placebo | DRUG | Available as Placebo matching tablet to GSK189075 |
| pioglitazone | DRUG | Active Control |
| GSK189075 oral tablets | DRUG | - |
| GW869682 oral tablets | DRUG | - |
| Bupropion | DRUG | Bupropion will be available as sustained release film-coated tablets with a dose of 150 milligrams administered orally. |
| Metformin | DRUG | Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams. |
Inclusion Criteria: * Subjects with a documented diagnosis of T2DM and HbA1c ≥7.0% and ≤9.5% measured by the central laboratory at Visit 1. * Note: Subjects with HbA1c \<7.5% must have a fasting fingerstick glucose ≥7 mmol/L (126 mg/dL) at Week 0, prior to randomization. * Note: The proportion...