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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01517373
First received: January 20, 2012
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: PF-04937319 10 mg
Drug: PF-04937319 50 mg
Drug: PF-04937319 100 mg
Drug: Glimepiride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from Baseline over 12-weeks in glycosylated hemoglobin - HbA1C [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline over 12-weeks in fasting plasma glucose [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects achieving HbA1C <6.5% and <7% at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo to match PF-04937319 and glimepiride
Drug: Placebo
Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
Experimental: PF-04937319 10 mg 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
Experimental: PF-04937319 50 mg 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
Experimental: PF-04937319 100 mg 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
Active Comparator: Glimepiride 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517373

  Show 52 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01517373     History of Changes
Other Study ID Numbers: B1621002
Study First Received: January 20, 2012
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
T2DM
PF-04937319
Phase 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014