drugset / Trial / NCT01863667
A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.
Timeline
- Start
- 2013-07-08
- Primary completion
- 2014-04-03
- Completion
- 2014-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glimepiride | Small molecule | 1 mg | Oral |
| Subject | Glimepiride | Small molecule | 2 mg | Oral |
| Subject | Glimepiride | Small molecule | 6 mg | Oral |
| Subject | Omarigliptin | Small molecule | 25 mg | Oral |