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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00618007 |
Purpose
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
|
Eligibility| 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
Contacts and Locations
Show 80 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| 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 |
