drugset / Trial / NCT00086515
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Timeline
- Start
- 2004-06-30
- Primary completion
- 2005-07-20
- Completion
- 2007-02-02
Outcome
Met primary endpoint
registry p <0.001; Mean Difference (Final Values) -0.65 (95% CI -0.77 to -0.53) NCT00086515 ↗
Publications
- Background Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006 Dec;29(12):2638-43. doi: 10.2337/dc06-0706.
- Background Xu L, Man CD, Charbonnel B, Meninger G, Davies MJ, Williams-Herman D, Cobelli C, Stein PP. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on beta-cell function in patients with type 2 diabetes: a model-based approach. Diabetes Obes Metab. 2008 Dec;10(12):1212-20. doi: 10.1111/j.1463-1326.2008.00887.x. Epub 2008 May 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glipizide | Small molecule | 5 mg | Oral |
| Subject | Sitagliptin | Small molecule | 100 mg | Oral |
| Background | Metformin | Small molecule | 1500 mg | — |
| Background | Pioglitazone | Small molecule | 15 mg | — |