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

Sponsor:	Hollis-Eden Pharmaceuticals
Information provided by:	Hollis-Eden Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00991107

Purpose

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.

Condition	Intervention	Phase
Insulin Resistance	Drug: HE3286	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by Hollis-Eden Pharmaceuticals:

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 [ Time Frame: Study duration and 1-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	6
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HE3286: Experimental HE3286 20 mg (10 mg BID)	Drug: HE3286 HE3286 20 mg (10 mg BID) for 28 days

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991107

Contacts

Contact: HollisEden Clinical Trials

858-320-2591

clinicaltrials@holliseden.com

Locations

United States, Louisiana
Clinical Site	Recruiting
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Hollis-Eden Pharmaceuticals

Investigators

Study Director:

Dwight R. Stickney, MD

Hollis-Eden Pharmaceuticals

More Information

No publications provided

Responsible Party:	Hollis-Eden Pharmaceuticals ( Dwight R. Stickney, MD - Chief Medical Officer )
Study ID Numbers:	HE3286-0103
Study First Received:	October 5, 2009
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00991107 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hollis-Eden Pharmaceuticals:

phase I
safety
tolerance
insulin resistance
obese

Additional relevant MeSH terms:

Hyperinsulinism
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs

Insulin Resistance
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010