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

NCT ID: NCT00991107

Last Updated: 2011-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-08-31

Brief Summary

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.

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HE3286

HE3286 20 mg (10 mg BID)

Group Type: EXPERIMENTAL

HE3286

Intervention Type: DRUG

HE3286 20 mg (10 mg BID) for 28 days

Interventions

HE3286

HE3286 20 mg (10 mg BID) for 28 days

Intervention Type: DRUG

Other Intervention Names

TRIOLEX

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harbor Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Hollis-Eden Pharmaceuticals

Principal Investigators

Dwight R. Stickney, MD

Role: STUDY_DIRECTOR

Harbor Therapeutics

Locations

Clinical Site

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

HE3286-0103

Identifier Type: -

Identifier Source: org_study_id