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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00673465 | Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338)(COMPLETED) | PHASE1 | COMPLETED | 17 | — | — | Apr 17, 2008 | Dec 11, 2008 | Sep 10, 2018 | - | — |
Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.
Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.
| Arm | Type | Description |
|---|---|---|
| Treatment sequence 1: SCH 497079 → Placebo → Metformin | EXPERIMENTAL | Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks. |
| Treatment sequence 2: Placebo → Metformin → SCH 497079 | EXPERIMENTAL | Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks. |
| Treatment sequence 3: Metformin → SCH 497079 → Placebo | EXPERIMENTAL | Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks. |
| Treatment sequence 4: SCH 497079 → Metformin → Placebo | EXPERIMENTAL | Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks. |
| Treatment sequence 5: Placebo → SCH 49709 → Metformin | EXPERIMENTAL | Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks. |
| Treatment sequence 6: Metformin → Placebo → SCH 497079 | EXPERIMENTAL | Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| SCH 497079 | DRUG | SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks |
| Placebo | DRUG | Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks |
| Metformin | DRUG | Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose) |
Inclusion Criteria: * \>=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants) * Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other change...