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 21, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517373

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Roseville, California, United States, 95661
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
Pfizer Investigational Site
Bradenton, Florida, United States, 34208
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33027
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Massachusetts
Pfizer Investigational Site
Hyannis, Massachusetts, United States, 02601
United States, North Carolina
Pfizer Investigational Site
Morehead City, North Carolina, United States, 28557
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45255
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45246
United States, South Carolina
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
Bristol, Tennessee, United States, 37620
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37404
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37411
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78728
Pfizer Investigational Site
Bryan, Texas, United States, 77802
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23502
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Bulgaria
Pfizer Investigational Site
Byala, Bulgaria, 7100
Pfizer Investigational Site
Ruse, Bulgaria, 7002
Pfizer Investigational Site
Sevlievo, Bulgaria, 5400
Pfizer Investigational Site
Sofia, Bulgaria, 1606
Pfizer Investigational Site
Sofia, Bulgaria, 1431
Pfizer Investigational Site
Stara Zagora, Bulgaria, 6003
Canada, British Columbia
Pfizer Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Pfizer Investigational Site
Surrey, British Columbia, Canada, V3S 2N6
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R2V 4W3
Canada, Ontario
Pfizer Investigational Site
Brampton, Ontario, Canada, L6T 0G1
Pfizer Investigational Site
Strathroy, Ontario, Canada, N7G 1Y7
Pfizer Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Pfizer Investigational Site
St-Romuald, Quebec, Canada, G6W 5M6
Pfizer Investigational Site
Terrebonne, Quebec, Canada, J6V 1S8
Canada
Pfizer Investigational Site
Quebec, Canada, G3K 2P8
Hungary
Pfizer Investigational Site
Balassagyarmat, Hungary, 2660
Pfizer Investigational Site
Budapest, Hungary, 1083
Pfizer Investigational Site
Budapest, Hungary, 1036
Pfizer Investigational Site
Szekesfehervar, Hungary, 8000
India
Pfizer Investigational Site
Bangalore, Karnataka, India, 560060
Pfizer Investigational Site
Pune, Maharashtra, India, 411 004
Pfizer Investigational Site
Pune, Maharashtra, India, 411 011
Slovakia
Pfizer Investigational Site
Banska Bystrica, Slovakia, 975 17
Pfizer Investigational Site
Moldava Nad Bodvou, Slovakia, 045 01
Pfizer Investigational Site
Nove Zamky, Slovakia, 940 01
Pfizer Investigational Site
Pezinok, Slovakia, 902 01
Pfizer Investigational Site
Zilina, Slovakia, 010 01
Taiwan
Pfizer Investigational Site
Taichung, Taiwan, 40447
Pfizer Investigational Site
Taipei, Taiwan, 110
Pfizer Investigational Site
Taipei, Taiwan, 100
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 21, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014