Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
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.
Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the
treatment of Type 2 diabetes. The investigational drug, HE3286, holds the potential to be
the first in a new class of insulin sensitizers with a potentially novel mechanism of action
that may improve the current therapeutic options available to a T2DM patient.
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. Changes in hemoglobin A1c (HbA1c) will be
assessed over a treatment period of 12-weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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