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

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991107
• Other study ID #: HE3286-0103
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2009
• Last updated: March 8, 2011
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2011
• Source: Harbor Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• HE3286
HE3286 20 mg (10 mg BID) for 28 days

Locations

Country	Name	City	State
United States	Clinical Site	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Harbor Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects		Study duration and 1-month follow-up	No
Secondary	Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.		Study period (28-days)	No