Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus

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.

Main Inclusion Criteria:

• Patient with a diagnosis of Type 2 Diabetes Mellitus (T2DM)
• Patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening.
• Patient with a fasting blood glucose level of ≤ 225 mg/dL at screening (≤ 255 mg/dl for drug-naive patients);
• Patient with HbA1c levels >7.5% (7.0 - 10.5% for drug-naive patients) at screening;
• Patient with BMI 28-37 kg/m2 for females 28-39 kg/m2 for males

Main Exclusion Criteria:

• Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;
• Patient with unstable diabetic complications requiring treatment or ongoing active intervention;
• Patient with a history of long term insulin therapy within the past year;
• Patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;
• Patient who has any clinically significant abnormalities in laboratory results at screening;