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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 Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 345 |
| Start date | 2011-11 |
| Completion | 2013-01 |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- Placebo
- PF-04937319 - 3mg
- PF-04937319 - 20mg
- PF-04937319 - 50mg
- PF-04937319 - 100mg
- Sitagliptin - 100mg
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 in participants were reported.
Countries
United States, Hungary, India, Philippines, Romania, Slovakia, South Africa, Taiwan