Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

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 - Not Applicable

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/07/002798

Enrollment

300

Registered

2012-07-16

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- Type 2 Diabetes Mellitus

Interventions

Intervention1: Experimental: PF-04937319 - Dose 1: Drug: PF-04937319 - 3mg PF-04937319 3mg administered as tablets once-daily for 84-days Intervention2: Experimental: PF-04937319 - Dose 2: Drug: PF

Eligibility

Inclusion criteria

Inclusion criteria: patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion criteria

Exclusion criteria: patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening

Design outcomes

Primary

Measure	Time frame
1. HbA1C - change from baselineTimepoint: 84 days	—

Secondary

Measure	Time frame
1. Fasting plasma glucose - change from baselineTimepoint: 84-days;2. Adverse eventsTimepoint: 84 days;3. Vitals - systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rateTimepoint: 84 days;4. 12-lead electrocardiograms (ECGs)Timepoint: 84 days;5. Body weightTimepoint: 84 days;6. Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysisTimepoint: 84 days	—

Countries

Hungary, India, Philippines, Romania, Slovakia, South Africa, 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