Type II Diabetes Mellitus Clinical Trial
Official title:
A Phase IIa, Multicenter, Placebo- and Active-controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo in Subjects With Type 2 Diabetes Mellitus
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.
n/a
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