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

NCT01517373 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2017-01-31

Study results available
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Summary

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days

DRUG

PF-04937319 10 mg

Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days

DRUG

PF-04937319 50 mg

Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days

DRUG

PF-04937319 100 mg

Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days

DRUG

Glimepiride

Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Hungary
  • India
  • Slovakia
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517373 on ClinicalTrials.gov