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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00337610 | Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 190 | — | — | Jun 1, 2006 | Aug 1, 2007 | May 12, 2016 | - | — |
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
| Arm | Type | Description |
|---|---|---|
| sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day | EXPERIMENTAL | - |
| sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day | DRUG | Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets. |
| comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day | DRUG | Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets. |
Inclusion Criteria: * Patient has type 2 diabetes mellitus * Males * Females who are highly unlikely to become pregnant * Patients poorly controlled while taking one or two oral antidiabetic medications Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacid...