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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: HE3286

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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92805
    • Anaheim, California, United States, 92801
    • Beverly Hills, California, United States, 90211
    • Buena Park, California, United States, 90620
    • Burbank, California, United States, 91505
    • Carmichael, California, United States, 95608
    • Escondido, California, United States, 92025
    • Fresno, California, United States, 93726
    • Huntington Park, California, United States, 90255
    • Long Beach,, California, United States, 90806
    • Los Angeles, California, United States, 90057
    • National City, California, United States, 91950
    • Roseville, California, United States, 95661
  • Illinois
    • Chicago, Illinois, United States, 60616
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
  • Missouri
    • St. Louis, Missouri, United States, 63141
  • Nevada
    • Las Vegas, Nevada, United States, 89148
    • Las Vegas, Nevada, United States, 89106
  • Texas
    • El Paso, Texas, United States, 79905
    • San Antonio, Texas, United States, 78229
  • Utah
    • Salt Lake City, Utah, United States, 84107
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsules BID	Drug: Placebo; Placebo capsules BID
Experimental: Active; HE3286 10 mg (5 mg BID)	Drug: HE3286; HE3286 10 mg per day (5 mg BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Harbor Therapeutics
• Investigators: Study Director: Dwight R. Stickney, MD, Harbor Therapeutics

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: June 6, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (Estimate): June 10, 2008

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 11, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: HbA1c; Metformin; Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HE3286-0401