A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- 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 ] [ Designated as safety issue: No ]
- Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects. [ Time Frame: Study period (28-days) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
HE3286 20 mg (10 mg BID)
HE3286 20 mg (10 mg BID) for 28 days
Other Name: TRIOLEX
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.