Status:
COMPLETED
A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
Lead Sponsor:
Harbor Therapeutics
Conditions:
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00991107
Start Date
September 1 2009
End Date
August 1 2010
Last Update
March 9 2011
Active Locations (1)
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1
Clinical Site
Baton Rouge, Louisiana, United States, 70808