A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
Summary
This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM) administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG) levels compared to placebo (PLA). The primary safety hypothesis was that MK-3577 is well tolerated compared to placebo.
Timeline
- Start
- 2009-03-24
- Primary completion
- 2010-07-12
- Completion
- 2010-07-13
Outcome
Met primary endpoint
Stopped (Enrollment): “Upon interim analysis, sufficient data was accrued to assess study hypotheses.”
registry Placebo (PLA) vs MK-3577 AM; p = 0.013; Least Squares Mean (LSM) Difference -17.2 (90% CI -28.3 to -6.1) NCT00868790 ↗
registry Placebo (PLA) vs MK-3577 PM; p <0.001; LSM Difference -23.4 (90% CI -34.5 to -12.4) NCT00868790 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-3577 | Small molecule | 6 mg | Oral |
| Subject | MK-3577 | Small molecule | 10 mg | Oral |
| Subject | MK-3577 | Small molecule | 25 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | — |