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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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35242
United States, California
Los Gatos, California, United States, 95032
Los Angeles, California, United States, 90057
Fresno, California, United States, 93720
Calabasas, California, United States, 91307
Artesia, California, United States
Santa Ana, California, United States
United States, Colorado
Colorado Springs, Colorado, United States, 80909
United States, Florida
Longwood, Florida, United States, 32779
South Miami, Florida, United States, 33143
Tampa, Florida, United States, 33614
Ocala, Florida, United States, 34471
Orlando, Florida, United States, 32806
Chiefland, Florida, United States, 32626
Hollywood, Florida, United States, 33021
Miami, Florida, United States, 33126
Miami Beach, Florida, United States, 33140
United States, Georgia
Rome, Georgia, United States, 30165
Dunwoody, Georgia, United States, 30338
United States, Illinois
Belleville, Illinois, United States, 62220
United States, Kansas
Shawnee Mission, Kansas, United States, 66216
United States, Maine
Bangor, Maine, United States, 04401
United States, Maryland
Columbia, Maryland, United States, 21045
United States, Michigan
Sterling Heights, Michigan, United States, 48314
United States, Missouri
St. Louis, Missouri, United States, 63141
St. Louis, Missouri, United States, 63128
Florissant, Missouri, United States, 63031
United States, Nevada
Las Vegas, Nevada, United States, 89101
United States, New York
Spring Garden, New York, United States, 11413
West Seneca, New York, United States, 14224
New York, New York, United States, 10016
United States, North Carolina
New Bern, North Carolina, United States, 28562
Mooresville, North Carolina, United States, 28117
Calabash, North Carolina, United States, 95032
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Norton, Ohio, United States, 44614
Kettering, Ohio, United States, 45429
United States, Oklahoma
Norman, Oklahoma, United States, 73071
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16601
Jenkintown, Pennsylvania, United States, 19046
Harleysville, Pennsylvania, United States, 19438
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Spartanburg, South Carolina, United States, 29303
Greenville, South Carolina, United States, 29615
North Myrtle Beach, South Carolina, United States, 29582
United States, Tennessee
Bristol, Tennessee, United States, 37620
United States, Texas
Houston, Texas, United States, 77090
North Richland Hills, Texas, United States, 76180
Austin, Texas, United States, 78705
Waco, Texas, United States, 76710
Houston, Texas, United States, 77004
Midland, Texas, United States, 79705
San Antonio, Texas, United States, 78229
Houston, Texas, United States, 77074
Temple, Texas, United States, 76502
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77081
Houston, Texas, United States, 77023
Georgetown, Texas, United States
United States, Virginia
Burke, Virginia, United States, 22015
Hampton, Virginia, United States, 23666
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53209
Puerto Rico
Ponce, Puerto Rico, 00716
Fajardo, Puerto Rico, 00738
San Juan, Puerto Rico, 00909-1711
Carolina, Puerto Rico, 00983
San Juan, Puerto Rico, 00926-2832
Rio Grande, Puerto Rico, 00745
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 14, 2009



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