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

This study has been completed.
Sponsor:
Information provided by:
Harbor Therapeutics
ClinicalTrials.gov Identifier:
NCT00694057
First received: June 6, 2008
Last updated: June 11, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: HE3286
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Harbor Therapeutics:

Primary Outcome Measures:
  • To evaluate the change in HbA1c from baseline to week 12 in the HE3286 treated group when compared to the placebo group. [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerance of HE3286 10 mg per day (5 mg BID) compared to placebo from baseline to week 12. [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of HE3286 on fasting blood glucose over time. [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of HE3286 on insulin sensitivity over time. [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: June 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694057

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
United States, Illinois
Chicago, Illinois, United States, 60616
United States, Louisiana
Baton Rouge, Louisiana, United States, 70808
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, Nevada
Las Vegas, Nevada, United States, 89106
Las Vegas, Nevada, United States, 89148
United States, Texas
El Paso, Texas, United States, 79905
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Wisconsin
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Harbor Therapeutics
Investigators
Study Director: Dwight R. Stickney, MD Harbor Therapeutics
  More Information

No publications provided

Responsible Party: Dwight Stickney, MD - Chief Medical Officer, Hollis-Eden Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00694057     History of Changes
Other Study ID Numbers: HE3286-0401
Study First Received: June 6, 2008
Last Updated: June 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Harbor Therapeutics:
Type 2 Diabetes Mellitus
Metformin
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014