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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
164
Unnamed facility
Anaheim, California, United States
Unnamed facility
Anaheim, California, United States
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.
Time frame: 12-weeks
To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12.
Time frame: 12-weeks
To evaluate the effect of HE3286 on fasting blood glucose over time.
Time frame: 12-weeks
To evaluate the effect of HE3286 on insulin sensitivity over time.
Time frame: 12-weeks
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Unnamed facility
Beverly Hills, California, United States
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Buena Park, California, United States
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Burbank, California, United States
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Carmichael, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Huntington Park, California, United States
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Long Beach, California, United States
...and 12 more locations