A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)
Status:
Terminated
Trial end date:
2017-04-18
Target enrollment:
Participant gender:
Summary
This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide;
Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes
mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000
mg/day).
The trial will include a 1-week screening period; at least an 8-week antihyperglycemic agent
(AHA) washout period, if required; a 14-week blinded therapy period (which includes
single-blind run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks
after the last dose of investigational product.
The primary hypothesis of the trial is that MK-8521 provides greater reduction in hemoglobin
A1C relative to placebo after 12 weeks of once-daily administration in participants with T2DM
with inadequate glycemic control on metformin monotherapy.