Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects | NCT00478322 | Trialant
CompletedInterventionalPhase 2Updated Dec 6, 2016
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
ClinicalTrials.gov ID
NCT00478322
Lead Sponsor
Incyte CorporationINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
24Actual
Last Update Posted
Dec 6, 2016Estimated
Start Date
Apr 2007
Primary Completion Date
Nov 2007Actual
Completion Date
Feb 2008Actual
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.
Diabetes Mellitus, Type 2
Obesity
Placebo
INCB013739
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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 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.