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

Pfizer53 sites in 6 countries304 target enrollmentFebruary 2012

ConditionsDiabetes Mellitus, Type 2

InterventionsPlacebo PF-04937319 10 mg PF-04937319 50 mg PF-04937319 100 mg Glimepiride

DrugsPlacebo PF-04937319 10 mg PF-04937319 50 mg PF-04937319 100 mg Glimepiride

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Diabetes Mellitus, Type 2
Sponsor: Pfizer
Enrollment: 304
Locations: 53
Primary Endpoint: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

January 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria

•Subjects with recent cardiovascular events, those with evidence of diabetic complications

Arms & Interventions

Placebo

Placebo to match PF-04937319 and glimepiride

Intervention: Placebo

PF-04937319 10 mg

Intervention: PF-04937319 10 mg

PF-04937319 50 mg

Intervention: PF-04937319 50 mg

PF-04937319 100 mg

Intervention: PF-04937319 100 mg

Glimepiride

Intervention: Glimepiride

Outcomes

Primary Outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12

Time Frame: 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.

Secondary Outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8(Baseline (Day 1), Week 2, 4, 6, 8)
Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12(Baseline (Day 1), Week 2, 4, 6, 8, 12)
Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12(Week 12)
Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data(Baseline (Day 1) up to Week 14)
Number of Participants With Increase/Decrease From Baseline Vital Signs Data(Baseline (Day 1) up to Week 14)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days))
Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode(Baseline (Day 1) up to Week 14)
Number of Hypoglycemic Events (HAE) Episodes Per Participant(Baseline (Day 1) up to Week 14)
Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant(Baseline (Day 1) up to Week 14)
Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14(Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up))
Number of Participants With Abnormal Laboratory Values(Baseline (Day 1) up to Week 14)