Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

A 12-week, Phase 2, Randomized, Double-blind, Placebo Controlled, Dose-ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Pf-04991532 and Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/06/002745

Enrollment

300

Registered

2012-06-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetes Mellitus, Type 2

Interventions

Intervention1: Experimental: PF-04937319 10 mg: Drug: PF-04937319 10 mg Combination of tablets and capsules, dose of 10 mg, a total of 3 to 5 pills/dose, administered once daily for 84-days Interven

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-65 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion criteria

Exclusion criteria: Subjects with recent cardiovascular events, those with evidence of diabetic complications

Design outcomes

Primary

Measure	Time frame
1. Change from Baseline over 12-weeks in glycosylated hemoglobin - HbA1CTimepoint: up to 12 weeks	—

Secondary

Measure	Time frame
1. Change from Baseline over 12-weeks in fasting plasma glucoseTimepoint: up to 12 weeks;2. Proportion of Subjects achieving HbA1C less then 6.5% and less then 7% at Week 12Timepoint: 12 weeks	—

Countries

Bulgaria, Canada, Hungary, India, Slovakia, Taiwan, United States of America

Contacts

Public ContactSwapnali Raut

Representing Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026