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

Completed · Phase 1

Conditions studied: Insulin Resistance

In brief

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.

Key facts

Study ID

NCT00991107

Run by

Harbor Therapeutics

People needed

5

Starts

2009-09-01

Expected to finish

2010-08-01

Last updated by the study team

2011-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Site — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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