Back to resultsPharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
Primary Purpose
Diabetes Mellitus, Type 2, Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
INCB013739
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes;, Type II diabetes;, Non-insulin dependent diabetes;, Obesity
Eligibility Criteria
Inclusion Criteria:
- Have an established diagnosis of Type 2 Diabetes as determined by the investigator.
- Females will be postmenopausal for at least 1 year with documented FSH > 30 IU/L.
Exclusion Criteria:
- Hypertriglyceridemia > 500 mg/dL at screening.
- BMI > 40 kg/m2.
- Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
- History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
INCB013739
Matching Placebo
Arm Description
Outcomes
Primary Outcome Measures
Changes in lipid profile laboratory values
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Assessment of pharmacodynamics of INCB013739 through analysis of blood samples
Assessment of ECGs, physical examinations and laboratory values for adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00478322
Brief Title
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
Diabetes;, Type II diabetes;, Non-insulin dependent diabetes;, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCB013739
Arm Type
Experimental
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo of 100 mg BID
Intervention Type
Drug
Intervention Name(s)
INCB013739
Intervention Description
INCB013739 100 mg BID
Primary Outcome Measure Information:
Title
Changes in lipid profile laboratory values
Time Frame
Measured at baseline and weekly for four weeks
Title
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Time Frame
Measured at baseline and weekly for four weeks
Title
Assessment of pharmacodynamics of INCB013739 through analysis of blood samples
Time Frame
Measured at baseline and weekly for four weeks
Title
Assessment of ECGs, physical examinations and laboratory values for adverse events
Time Frame
Measured at baseline through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have an established diagnosis of Type 2 Diabetes as determined by the investigator.
Females will be postmenopausal for at least 1 year with documented FSH > 30 IU/L.
Exclusion Criteria:
Hypertriglyceridemia > 500 mg/dL at screening.
BMI > 40 kg/m2.
Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Levy, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
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