Skip to main content
OpenTrials
Completed

NCT Number: NCT00478322

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 thiazolidinediones, 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.

Treatment and study plan

Placebo

Drug

Matching placebo of 100 mg BID

INCB013739

Drug

INCB013739 100 mg BID

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
May 24, 2007
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.