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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00478322
First received: May 22, 2007
Last updated: March 13, 2012
Last verified: March 2012
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. [ Time Frame: Measured at baseline and weekly for four weeks ] [ Designated as safety issue: No ]
  • Assessment of pharmacodynamics of INCB013739 through analysis of blood samples [ Time Frame: Measured at baseline and weekly for four weeks ] [ Designated as safety issue: No ]
  • Assessment of ECGs, physical examinations and laboratory values for adverse events [ Time Frame: Measured at baseline through study completion ] [ Designated as safety issue: Yes ]

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

  Eligibility

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

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 thiazolidenediones, 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 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
Investigators
Study Director: Richard Levy, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00478322     History of Changes
Other Study ID Numbers: INCB 13739-201
Study First Received: May 22, 2007
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

ClinicalTrials.gov processed this record on July 31, 2014