A Phase II, Double Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerance and Activity of HE3286 When Administered Orally for 12 Weeks to Adult Patients With Type 2 Diabetes Mellitus
Abstract
This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks.
Conditions: Type 2 Diabetes Mellitus.
Primary outcome: To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.; To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12..
Enrollment: 164 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 164 participants or records.
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