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Sponsored by: |
Incyte Corporation |
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Information provided by: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT00698789 |
Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: INCB019602 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Double-Blind, Placebo Controlled, Randomized Study to Evaluate the Safety and Tolerability of INCB019602 Plus Metformin Compared to Metformin Alone in Type 2 Diabetic Subjects |
Estimated Enrollment: | 120 |
Study Start Date: | May 2008 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Dose 1 INCB019602
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Drug: INCB019602
INCB019602
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B: Experimental
Dose 2 INCB019602
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Drug: INCB019602
INCB019602
|
C: Experimental
Dose 3 INCB019602
|
Drug: INCB019602
INCB019602
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D: Experimental
Dose 4 INCB019602
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Drug: INCB019602
INCB019602
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E: Experimental
Dose 5 INCB019602
|
Drug: INCB019602
INCB019602
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G: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Phoenix, Arizona, United States, 85029 | |
Tucson, Arizona, United States, 85705 | |
United States, California | |
Chula Vista, California, United States, 91911 | |
Orange, California, United States, 92869 | |
Mission Viejo, California, United States, 92691 | |
San Diego, California, United States, 92117 | |
Santa Ana, California, United States, 92701 | |
Tustin, California, United States, 92780 | |
Paramount, California, United States, 90723 | |
Los Angeles, California, United States | |
United States, Colorado | |
Colorado Springs, Colorado, United States, 80909 | |
United States, Florida | |
St. Petersburg, Florida, United States, 33709 | |
United States, Kansas | |
Shawnee Mission, Kansas, United States, 66216 | |
United States, Louisiana | |
Shreveport, Louisiana, United States, 71101 | |
United States, Michigan | |
Dearborn, Michigan, United States, 48126 | |
United States, Missouri | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Omaha, Nebraska, United States, 68154 | |
United States, New Jersey | |
Elizabeth, New Jersey, United States, 07202 | |
United States, North Carolina | |
Charlotte, North Carolina, United States, 28211 | |
United States, Oklahoma | |
Oklahoma City, Oklahoma, United States, 73103 | |
United States, Rhode Island | |
East Providence, Rhode Island, United States, 02914 | |
United States, Texas | |
San Antonio, Texas, United States, 78229 |
Responsible Party: | Incyte Corporation ( Pam Murphy, VP Investor Relations and Corporate Communication ) |
Study ID Numbers: | INCB 19602-201 |
Study First Received: | June 13, 2008 |
Last Updated: | February 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00698789 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |