Clinical trial NCT00991107: A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Keywords: phase I
safety
tolerance
insulin resistance
obese
Lead sponsor: Harbor Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects
timeFrame: Study duration and 1-month follow-up
Secondary outcomes:
measure: Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
timeFrame: Study period (28-days)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Clinical Site
state: Louisiana
Study officials:
affiliation: Harbor Therapeutics
name: Dwight R. Stickney, MD
role: STUDY_DIRECTOR
References: