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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478322
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : December 6, 2016
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Drug: Placebo Drug: INCB013739 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: INCB013739 Drug: INCB013739
INCB013739 100 mg BID

Placebo Comparator: Matching Placebo Drug: Placebo
Matching placebo of 100 mg BID

Primary Outcome Measures :
  1. Changes in lipid profile laboratory values [ Time Frame: Measured at baseline and weekly for four weeks ]
  2. Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. [ Time Frame: Measured at baseline and weekly for four weeks ]
  3. Assessment of pharmacodynamics of INCB013739 through analysis of blood samples [ Time Frame: Measured at baseline and weekly for four weeks ]
  4. Assessment of ECGs, physical examinations and laboratory values for adverse events [ Time Frame: Measured at baseline through study completion ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hypertriglyceridemia > 500 mg/dL at screening.
  2. BMI > 40 kg/m2.
  3. Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
  4. History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478322

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
Study Director: Richard Levy, MD Incyte Corporation

Responsible Party: Incyte Corporation Identifier: NCT00478322     History of Changes
Other Study ID Numbers: INCB 13739-201
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by Incyte Corporation:
Type II diabetes;
Non-insulin dependent diabetes;

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases