Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
NCT ID: NCT01517373
Last Updated: 2017-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
304 participants
INTERVENTIONAL
2012-02-29
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo to match PF-04937319 and glimepiride
Placebo
Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
PF-04937319 10 mg
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
PF-04937319 50 mg
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
PF-04937319 100 mg
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
Glimepiride
Glimepiride
Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days
Interventions
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Placebo
Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
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
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
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
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 Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Sierra Clinical Research
Roseville, California, United States
California Research Foundation
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Meridien Research
Bradenton, Florida, United States
South Broward Research, LLC
Pembroke Pines, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Clinical Research Center of Cape Cod, Inc.
Hyannis, Massachusetts, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Holston Medical Group
Bristol, Tennessee, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Diagnostic Center
Chattanooga, Tennessee, United States
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Bristol Clinical Research, LLC
Austin, Texas, United States
DiscoveResearch, Inc.
Bryan, Texas, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
Aurora Advanced Healthcare, Inc.
Milwaukee, Wisconsin, United States
MBAL Yulia Vrevska - Byala, Otdelenie po vatreshni bolesti
Byala, , Bulgaria
MBAL - Ruse AD, Vtoro otdelenie po vatreshni bolesti
Rousse, , Bulgaria
DKTs Akta Medika, Kabinet po endokrinologia
Sevlievo, , Bulgaria
UMBAL Aleksandrovska, Klinika po endokrinologia i bolesti na obmyanata
Sofia, , Bulgaria
VMA - MBAL - Sofia, Klinika po endokrinologia i bolesti na obmyanata
Sofia, , Bulgaria
UMBAL Stara Zagora, Klinika po endokrinologia i bolesti na obmyanata
Stara Zagora, , Bulgaria
Glover Medical Clinic
Langley, British Columbia, Canada
Ocean West Research Clinic Inc.
Surrey, British Columbia, Canada
Rivergrove Medical Clinic
Winnipeg, Manitoba, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
DCTM CLinical Trials Group Ltd.
Strathroy, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Alpha Recherche Clinique
Québec, Quebec, Canada
Pro-Recherche
Saint Romuald, Quebec, Canada
Centre de cardiologie et de Recherche Clinique Pierre-Le Gardeur
Terrebonne, Quebec, Canada
Dr. Kenessey Albert Korhaz-Rendelointezet/Belgyogyaszat
Balassagyarmat, , Hungary
Synexus Magyarorszag Kft.
Budapest, , Hungary
Semmelweis Egyetem/I. sz. Belgyogyaszati Klinika
Budapest, , Hungary
Fejer Megyei Szent Gyorgy Korhaz/II. Belgyogyaszati Osztaly
Székesfehérvár, , Hungary
BGS Global Hospital
Bangalore, Karnataka, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
Diabetes Unit, K.E.M. Hospital Research Centre
Pune, Maharashtra, India
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica, , Slovakia
Interna A Diabetologicka Ambulancia
Moldava nad Bodvou, , Slovakia
FUNKYSTUFF, s.r.o.
Nové Zámky, , Slovakia
MEDIAB, s.r.o.
Pezinok, , Slovakia
MEDIVASA, s.r.o.
Žilina, , Slovakia
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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References
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Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-005206-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1621002
Identifier Type: -
Identifier Source: org_study_id
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