Overview
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
Status:
Completed
Completed
Trial end date:
2008-02-01
2008-02-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Incyte Corporation
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 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.