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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harbor Therapeutics
• Treatments: Dehydroepiandrosterone

Criteria

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;