Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects

This study has been completed.

First Received: May 22, 2007 Last Updated: January 8, 2009 History of Changes

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00478322

Purpose

Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to participants interested in the trial).

Condition	Intervention	Phase
Diabetes Mellitus Type 2; Obesity	Drug: INCB013739	Phase II

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures:

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Estimated Enrollment:	24
Study Start Date:	April 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have an established diagnosis of Type 2 Diabetes as determined by the investigator.
Females will be postmenopausal for at least 1 year with documented FSH > 30 IU/L.

Exclusion Criteria:

Hypertriglyceridemia > 500 mg/dL at screening.
BMI > 40 kg/m2.
Receiving thiazolidenediones, insulin, or exenatide within the 3 months prior to screening.
History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478322

Locations

United States, California

Chula Vista, California, United States, 91911
United States, New York

Bronx, New York, United States, 10461
United States, Texas

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Incyte Corporation

More Information

No publications provided

Study ID Numbers:	INCB 13739-201
Study First Received:	May 22, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00478322 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

Diabetes;
Type II diabetes;
Non-insulin dependent diabetes;
Obesity

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin
Body Weight

Signs and Symptoms
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009