drugset / Trial / NCT01890122
Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes
RandomizedFactorialQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).
Timeline
- Start
- 2013-09
- Primary completion
- 2015-09
- Completion
- 2015-10
Outcome
Met primary endpoint
registry Metformin HCl 500 mg vs Alogliptin 12.5 mg + Metformin HCl 500 mg FDC; p < 0.0001; Least Square Mean Difference -0.49 (95% CI -0.700 to -0.278); ANCOVA NCT01890122 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alogliptin | Unknown | 12.5 mg | Oral |
| Subject | Alogliptin | Unknown | 500 mg | Oral |
| Comparator | Metformin | Small molecule | 500 mg | Oral |