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

Incyte

Status and phase: Completed; Phase 2

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: INCB013739

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478322

INCB 13739-201

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

INCB013739

Experimental group

Treatment:

Drug: INCB013739

Matching Placebo

Placebo Comparator group

Treatment:

Drug: Placebo