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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00473525 |
The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Placebo Drug: PF-00734200 10 mg QD Drug: PF-00734200 20 mg QD Drug: PF-00734200 5 mg QD Drug: PF-00734200 2 mg QD |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin |
Enrollment: | 303 |
Study Start Date: | June 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator |
Drug: Placebo
Placebo QD
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PF-00734200 10 mg QD: Experimental |
Drug: PF-00734200 10 mg QD
10 mg QD
|
PF-00734200 20 mg QD: Experimental |
Drug: PF-00734200 20 mg QD
20 mg QD
|
PF-00734200 5 mg QD: Experimental |
Drug: PF-00734200 5 mg QD
5 mg QD
|
PF-00734200 2 mg QD: Experimental |
Drug: PF-00734200 2 mg QD
2 mg QD
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A7941005 |
Study First Received: | May 14, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00473525 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |