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

This study has been completed.
Information provided by (Responsible Party):
Incyte Corporation Identifier:
First received: May 22, 2007
Last updated: December 2, 2016
Last verified: December 2016
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 Intervention Phase
Diabetes Mellitus, Type 2 Obesity Drug: Placebo Drug: INCB013739 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Incyte Corporation:

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

Enrollment: 24
Study Start Date: April 2007
Study Completion Date: February 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB013739 Drug: INCB013739
INCB013739 100 mg BID
Placebo Comparator: Matching Placebo Drug: Placebo
Matching placebo of 100 mg BID


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Incyte Corporation Identifier: NCT00478322     History of Changes
Other Study ID Numbers: INCB 13739-201
Study First Received: May 22, 2007
Last Updated: December 2, 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 processed this record on September 21, 2017