We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991107
First Posted: October 7, 2009
Last Update Posted: March 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Harbor Therapeutics
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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 ]

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) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 5, 2009
First Posted: October 7, 2009
Last Update Posted: March 9, 2011
Last Verified: March 2011

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, Globin Zinc
Insulin
Dehydroepiandrosterone
Hypoglycemic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors