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A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production

This study has been completed.
Sponsor:
Information provided by:
Harbor Therapeutics
ClinicalTrials.gov Identifier:
NCT00991107
First received: October 5, 2009
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.


Condition Intervention Phase
Insulin Resistance
 Drug: HE3286
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open Label Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production When Administered Orally to Obese Insulin-Resistant Adult Subjects for 28 Days

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harbor Therapeutics:

Primary Outcome Measures:
  • Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects [ Time Frame: Study duration and 1-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects. [ Time Frame: Study period (28-days) ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HE3286
HE3286 20 mg (10 mg BID)
 Drug: HE3286
HE3286 20 mg (10 mg BID) for 28 days
Other Name: TRIOLEX

Detailed Description:

Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes mellitus (T2DM). The investigational drug, HE3286, is a synthetic analog of a naturally occurring hormone with a potentially new mechanism of action that may improve the current therapeutic options available to a T2DM patient.

The glucose clamp is the gold standard for measurement of insulin sensitivity. Given the observed activity of HE3286 in reducing insulin resistance in both impaired glucose intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the physiological site of action (i.e. liver vs. skeletal muscle) of HE3286 in order to further understand the mechanism of action and to design future clinical trials.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subject 18-65 years of age
  • Body Mass Index (BMI) is at least 29 kg/m2 but no more than 35 kg/m2 for females and no more than 37 kg/m2 for males
  • Subject has fasting blood glucose level of < 126 mg/dL at Screening
  • Subject has a 2 hour postprandial (following 75 grams glucose administration) blood glucose of 140-200 mg/dL at Screening
  • Subject has fasting plasma insulin >=10 μU/mL

Exclusion Criteria:

  • Subject has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, clinically significant endocrine disorders (including history of diabetes); or clinically significant neurological or psychiatric condition;
  • Subject has any clinically significant abnormalities in laboratory results at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991107

Locations
United States, Louisiana
Clinical Site
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Harbor Therapeutics
Investigators
Study Director: Dwight R. Stickney, MD Harbor Therapeutics
  More Information

No publications provided

Responsible Party: Dwight R. Stickney, MD - Chief Medical Officer, Hollis-Eden Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00991107     History of Changes
Other Study ID Numbers: HE3286-0103
Study First Received: October 5, 2009
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Harbor Therapeutics:
phase I
safety
tolerance
insulin resistance
obese

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013