Back to resultsA Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HE3286
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring phase I, safety, tolerance, insulin resistance, obese
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
Sites / Locations
- Clinical Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HE3286
Arm Description
HE3286 20 mg (10 mg BID)
Outcomes
Primary Outcome Measures
Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects
Secondary Outcome Measures
Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00991107
Brief Title
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
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Harbor Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
phase I, safety, tolerance, insulin resistance, obese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HE3286
Arm Type
Experimental
Arm Description
HE3286 20 mg (10 mg BID)
Intervention Type
Drug
Intervention Name(s)
HE3286
Other Intervention Name(s)
TRIOLEX
Intervention Description
HE3286 20 mg (10 mg BID) for 28 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.
Time Frame
Study period (28-days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight R. Stickney, MD
Organizational Affiliation
Harbor Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
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