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

NCT ID: NCT00478322

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-02-29

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 Obesity

Keywords

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Diabetes; Type II diabetes; Non-insulin dependent diabetes; Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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INCB013739

Group Type EXPERIMENTAL

INCB013739

Intervention Type DRUG

INCB013739 100 mg BID

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo of 100 mg BID

Interventions

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Placebo

Matching placebo of 100 mg BID

Intervention Type DRUG

INCB013739

INCB013739 100 mg BID

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Levy, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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Chula Vista, California, United States

Site Status

The Bronx, New York, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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INCB 13739-201

Identifier Type: -

Identifier Source: org_study_id