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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00618007 |
To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: PF-00734200 30 mg QD Drug: PF-00734200 20 mg QD Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment |
Estimated Enrollment: | 225 |
Study Start Date: | February 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
30 mg QD: Experimental |
Drug: PF-00734200 30 mg QD
30 mg QD
|
20 mg QD: Experimental |
Drug: PF-00734200 20 mg QD
20 mg QD
|
Placebo: Placebo Comparator |
Drug: Placebo
Placebo
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men or women between 18-80 years of age with poorly controlled Type 2 diabetes
Exclusion Criteria:
Type 1 or secondary forms of diabetes Currently using insulin
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A7941006 |
Study First Received: | February 5, 2008 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00618007 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |