Pharmacodynamic Study of the Effect of INCB013739 on Insu... | NCT00478322

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

NCT00478322

Sponsor

Incyte Corporation

Status

Completed

Last Update Posted

Dec 6, 2016Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Diabetes Mellitus, Type 2
Obesity

Interventions

Placebo
INCB013739

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Nov 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

May 22, 2007

First Submission Date that Met QC Criteria

May 22, 2007

First Posted Date

May 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INCB013739	Experimental		Drug: INCB013739
Matching Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Matching placebo of 100 mg BID	Matching Placebo
INCB013739

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Levy, MD	Incyte Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Chula Vista	California	91911	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided