drugset / Trial / NCT01640873

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

NCT01640873 ↗

Phase 1 Completed 33 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.

Timeline

Start
2012-09-19
Primary completion
2012-12-20
Completion
2012-12-20

Outcome

Missed primary endpoint

registry The posterior probability that the reduction in FPG is ≥ 20 mg/dL is 0.06, and hence, the FPG hypothesis was not met. NCT01640873 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8655 Unknown 320 mg Oral