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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Drug: INCB013739; Drug: Placebo

• Registration Number: NCT00478322
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-24
• Primary Completion: 2007-11
• Study Completion: 2008-02
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INCB013739	INCB013739	-
Matching Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in lipid profile laboratory values	Measured at baseline and weekly for four weeks
Assessment of pharmacodynamics of INCB013739 through analysis of blood samples	Measured at baseline and weekly for four weeks
Assessment of ECGs, physical examinations and laboratory values for adverse events	Measured at baseline through study completion
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.	Measured at baseline and weekly for four weeks