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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
  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:


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
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, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014