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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00698230
First received: June 13, 2008
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Drug: INCB013739
Drug: Placebo comparator matching INCB013739
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Change from Baseline to Week 12 in hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 12 (or early termination study visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to Week 12 in fasting plasma glucose (FPG). [ Time Frame: Baseline and Week 12 (or early termination study visit) ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698230

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

No publications provided by Incyte Corporation

Additional 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
Study First Received: June 13, 2008
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013