Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
1 other identifier
interventional
24
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started Apr 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 22, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedDecember 6, 2016
December 1, 2016
7 months
May 22, 2007
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in lipid profile laboratory values
Measured at baseline and weekly for four weeks
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
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
Study Arms (2)
INCB013739
EXPERIMENTALMatching Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
The Bronx, New York, 10461, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Levy, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2007
First Posted
May 24, 2007
Study Start
April 1, 2007
Primary Completion
November 1, 2007
Study Completion
February 1, 2008
Last Updated
December 6, 2016
Record last verified: 2016-12