We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00698230
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: INCB013739 Drug: Placebo comparator matching INCB013739 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects
Study Start Date : May 2008
Primary Completion Date : April 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment A - INCB013739 & Metformin
INCB013739 5 mg QD and Metformin
Drug: INCB013739
INCB013739 5 mg QD tablet
Experimental: Treatment B - INCB013739 & Metformin
INCB013739 15 mg QD and Metformin
Drug: INCB013739
INCB013739 15 mg QD tablet
Experimental: Treatment C - INCB013739 & Metformin
INCB013739 50 mg QD and Metformin
Drug: INCB013739
INCB013739 50 mg QD tablet
Experimental: Treatment D - INCB013739 & Metformin
INCB013739 100 mg QD and Metformin
Drug: INCB013739
INCB013739 100 mg QD tablet
Experimental: Treatment E - INCB013739 & Metformin
INCB013739 200 mg QD and Metformin
Drug: INCB013739
INCB013739 200 mg QD
Placebo Comparator: Treatment F - Placebo
Matching placebo
Drug: Placebo comparator matching INCB013739
Orally once daily tablet


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline to Week 12 in hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 12 (or early termination study visit) ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in fasting plasma glucose (FPG). [ Time Frame: Baseline and Week 12 (or early termination study visit) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established diagnosis of Type 2 Diabetes
  • Stable dose of metformin for more than 8 weeks

Exclusion Criteria:

  • Subjects with Addison's disease or Cushing's Syndrome
  • Type 1 diabetes mellitus or secondary forms of diabetes
  • Subjects with uncontrolled thyroid disease
  • History of renal impairment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698230


  Show 68 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Bill Williams, MD Incyte Corporation
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00698230     History of Changes
Other Study ID Numbers: INCB 13739-202
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs