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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: HE3286

• Registration Number: NCT00694057
• Lead Sponsor: Harbor Therapeutics

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-11
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules BID
Active	HE3286	HE3286 10 mg (5 mg BID)

Primary Outcome Measures

Name	Time	Method
To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group.	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.	12-weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of HE3286 on insulin sensitivity over time.	12-weeks
To evaluate the effect of HE3286 on fasting blood glucose over time.	12-weeks