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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478322
• Other study ID #: INCB 13739-201
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2007
• Last updated: December 2, 2016
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: December 2016
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Drug:
• Placebo
Matching placebo of 100 mg BID
• INCB013739
INCB013739 100 mg BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lipid profile laboratory values		Measured at baseline and weekly for four weeks	No
Primary	Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.		Measured at baseline and weekly for four weeks	No
Primary	Assessment of pharmacodynamics of INCB013739 through analysis of blood samples		Measured at baseline and weekly for four weeks	No
Primary	Assessment of ECGs, physical examinations and laboratory values for adverse events		Measured at baseline through study completion	Yes