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

This study is ongoing, but not recruiting participants.

First Received: June 13, 2008 Last Updated: April 27, 2009 History of Changes

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00698230

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	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Change from baseline in hemoglobin A1c (HbA1c) and safety and tolerability data. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose (FPG) and proportion of subjects meeting HbA1c goal. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose 1 INCB013739	Drug: INCB013739 INCB013739 tablet form
2: Experimental Dose 2 INCB013739	Drug: INCB013739 INCB013739 tablet form
3: Experimental Dose 3 INCB013739	Drug: INCB013739 INCB013739 tablet form
4: Experimental Dose 4 INCB013739	Drug: INCB013739 INCB013739 tablet form
5: Experimental Dose 5 INCB013739	Drug: INCB013739 INCB013739 tablet form
6: Placebo Comparator	Drug: Placebo Placebo 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

More Information

No publications provided

Responsible Party:	Incyte Corporation ( Pam Murphy, VP Investor Relations and Corporate Communication )
Study ID Numbers:	INCB 13739-202
Study First Received:	June 13, 2008
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00698230 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009