Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
NCT ID: NCT01475461
Last Updated: 2017-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
345 participants
INTERVENTIONAL
2011-11-30
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
double-dummy placebo tablets administered once-daily for 84-days
PF-04937319 - Dose 1
PF-04937319 - 3mg
PF-04937319 3mg administered as tablets once-daily for 84-days
PF-04937319 - Dose 2
PF-04937319 - 20mg
PF-04937319 20mg administered as tablets once-daily for 84-days
PF-04937319 - Dose 3
PF-04937319 - 50mg
PF-04937319 50mg administered as tablets once-daily for 84-days
PF-04937319 - Dose 4
PF-04937319 - 100mg
PF-04937319 100mg administered as tablets once-daily for 84-days
Sitagliptin
Sitagliptin - 100mg
Sitagliptin 100mg administered as tablets once-daily for 84-days
Interventions
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Placebo
double-dummy placebo tablets administered once-daily for 84-days
PF-04937319 - 3mg
PF-04937319 3mg administered as tablets once-daily for 84-days
PF-04937319 - 20mg
PF-04937319 20mg administered as tablets once-daily for 84-days
PF-04937319 - 50mg
PF-04937319 50mg administered as tablets once-daily for 84-days
PF-04937319 - 100mg
PF-04937319 100mg administered as tablets once-daily for 84-days
Sitagliptin - 100mg
Sitagliptin 100mg administered as tablets once-daily for 84-days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 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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Anaheim Clinical Trials
Anaheim, California, United States
National Research Institute
Los Angeles, California, United States
Encompass Clinical Research
Spring Valley, California, United States
The Family Doctors of Belleview
Belleview, Florida, United States
Swiss Medical Research
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Rockdale Medical Research Associates
Conyers, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Central Kentucky Research Associates, Inc.
Mount Sterling, Kentucky, United States
Mount Sterling Clinic
Mount Sterling, Kentucky, United States
The Office of Dr. Matthew S. Barton, MD
Las Vegas, Nevada, United States
TKL Research, Inc.
Paramus, New Jersey, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
PriMed Clinical Research
Kettering, Ohio, United States
PriMed Physicians
Kettering, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Medical Research South, LLC
Charleston, South Carolina, United States
Newton Family Medicine
Charleston, South Carolina, United States
Austin Center for Clinical Research
Austin, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Plano Primary Care Clinic
Plano, Texas, United States
Pioneer Research Solutions, Inc.
Sugar Land, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
DRC Kft.
Balatonfüred, , Hungary
Dr. Rethy Pal Korhaz-Rendelointezet
Békéscsaba, , Hungary
Qualiclinic Kft.
Budapest, , Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Kenezy Korhaz Rendelointezet Egeszsegugyi Nonprofit Kft.
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Polgar es Tersege Egeszsegugyi Kozpont Nonprofit Zrt.
Polgár, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Zala Megyei Korhaz
Zalaegerszeg, , Hungary
Bhatia Hospital
Mumbai, Maharashtra, India
Seth G S Medical College & KEM Hospital, Dept of Endocrinology,
Mumbai, Maharashtra, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, India
S.R. Kalla Memorial Gastro and General Hospital
Jaipur, Rajasthan, India
Vicente Sotto Memorial Medical Center
Cebu City, , Philippines
Institute for Studies on Diabetes Foundation Inc.
Marikina City, , Philippines
The Medical City
Pasig, , Philippines
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, Jud. Cluj, Romania
Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
Bucharest, , Romania
Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
Bucharest, , Romania
Metabolicke centrum MUDr. Katariny Raslovej, s.r.o.
Bratislava, , Slovakia
Medispektrum Plus, s.r.o.
Bratislava, , Slovakia
IN-DIA, s.r.o.
Lučenec, , Slovakia
MUDr. Zuzana Ochodnicka, Interna diabetologicka ambulancia, s.r.o.
Nitra, , Slovakia
NOEMIS, s.r.o.
Nové Mesto nad Váhom, , Slovakia
DIABETOL, s.r.o.
Prešov, , Slovakia
Areteus, s.r.o.
Trebišov, , Slovakia
Diabetes centrum, s.r.o.
Trenčín, , Slovakia
Bloemfontein Medi-Clinic
Bloemfontein, Free State, South Africa
Dr DR Lakha's Practice
Johannesburg, Gauteng, South Africa
Midrand Medical Centre
Midrand, Gauteng, South Africa
Medi-Clinic Heart Hospital
Pretoria, Gauteng, South Africa
Dr Bhana
Waverley, Gauteng, South Africa
Dr JH Mynhardt
Kimberley, Northern Cape, South Africa
Randles Road Medical Centre
Durban, , South Africa
AA Mahomed Medical Centre
Moloto South, , South Africa
Changhua Christian Hospital
Changhua, , Taiwan
Far Eastern Memorial Hospital, Division of Endocrinology and Metabolism
New Taipei City, , Taiwan
Taichung Veterans General Hospital, Division of Metabolism and Endocrinology
Taichung, , Taiwan
Chi Mei Medical Center
Tainan City, , 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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Other Identifiers
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2011-004002-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1621007
Identifier Type: -
Identifier Source: org_study_id
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