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A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 304 |
| Start date | 2012-02 |
| Completion | 2013-01 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- Placebo
- PF-04937319 10 mg
- PF-04937319 50 mg
- PF-04937319 100 mg
- Glimepiride
Primary outcomes
- Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 — Baseline (Day 1), Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.
Countries
United States, Bulgaria, Canada, Hungary, India, Slovakia, Taiwan