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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: HE3286
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsules BID | Drug: Placebo<br>* Placebo capsules BID<br>|
| Experimental: Active<br>HE3286 10 mg (5 mg BID) | Drug: HE3286<br>* HE3286 10 mg per day (5 mg BID)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of HE3286 on fasting blood glucose over time. |  | 12-weeks | 
| To evaluate the effect of HE3286 on insulin sensitivity over time. |  | 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Metformin, HbA1c