Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
NCT ID: NCT01864174
Last Updated: 2019-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1736 participants
INTERVENTIONAL
2013-06-20
2016-06-01
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
DOUBLE
Study Groups
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Arm 1: Metformin XR and Placebo matching with Metformin XR
Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks
Metformin XR
Placebo matching with Metformin XR
Arm 2: Metformin IR and Placebo matching with Metformin IR
Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks
Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks
Metformin IR
Placebo matching with Metformin IR
Interventions
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Metformin XR
Metformin IR
Placebo matching with Metformin XR
Placebo matching with Metformin IR
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone
* Women must have a negative serum or urine test within 24 hours prior to start of investigational product
Exclusion Criteria
* Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with \>10% weight loss during last 3 months
* Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40 mg/dL (124 μmol/L for female subjects)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Terence T. Hart, Md
Muscle Shoals, Alabama, United States
Clini Res Advantage Desert Clin Res, Llc
Mesa, Arizona, United States
Clinical Res Advantage Central
Phoenix, Arkansas, United States
Marin Endocrine Care And Research, Inc.
Greenbrae, California, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Actca
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
R. Srinivasan, M.D., Inc.
Monterey Park, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Valley Clinical Trials
Northridge, California, United States
Center For Clinical Trials Of Sacramento, Inc.
Sacramento, California, United States
Clinical Research Advantage
Colorado Springs, Colorado, United States
Clinical Research Advantage
Colorado Springs, Colorado, United States
Colorado Springs Family Practice
Colorado Springs, Colorado, United States
Clinical Research Advantage, Inc/Co Springs Health Partners, Briar
Colorado Springs, Colorado, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
Family Care Partners
Jacksonville, Florida, United States
Omega Research Consultants, Llc
Orlando, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
Gulfcoast Medical Research Center, Llc
Tampa, Florida, United States
Cedar-Crosse Research Ctr
Chicago, Illinois, United States
Clinical Research Advantage, Inc./Family Medicine Associates
Evansville, Indiana, United States
American Health Network Of In Llc
Muncie, Indiana, United States
Columbia Medical Practice
Columbia, Maryland, United States
Centennial Medical Group
Elkridge, Maryland, United States
Drs. Rodbard And Dempsey
Rockville, Maryland, United States
Ny Clinical Trials
New York, New York, United States
White Oak Family Physicians, Pa
Asheboro, North Carolina, United States
Metrolina Internal Medicine
Charlotte, North Carolina, United States
Medical Research Unlimited, Inc.
Cincinnati, Ohio, United States
Lion Research
Norman, Oklahoma, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Integrated Medical Group Pc / Fleetwood Medical Assoc.
Fleetwood, Pennsylvania, United States
Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina, United States
Holston Medical Group
Bristol, Tennessee, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
Covenant Clinical Research, Pa
San Antonio, Texas, United States
Independence Family Medicine
Virginia Beach, Virginia, United States
Local Institution
Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Brampton, Ontario, Canada
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Burlington, Ontario, Canada
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Collingwood, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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London, , Canada
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Brno, , Czechia
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České Budějovice, , Czechia
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Krnov, , Czechia
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Liberec, , Czechia
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Litomyšl, , Czechia
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Nový Jičín, , Czechia
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Ostrava-Kunčice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aschaffenburg, Bavaria, Germany
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Münster, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Berlin, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Löhne, , Germany
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Myen, , Germany
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Papenburg, , Germany
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Pirna, , Germany
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Pécs, Baranya, Hungary
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Szigetvár, Baranya, Hungary
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Sátoraljaújhely, Borsod-Abauj Zemplen county, Hungary
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Hodmezvasarhely, Csongrád megye, Hungary
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Csorna, , Hungary
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Debrecen, , Hungary
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Kecskemét, , Hungary
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Mosonmagyaróvár, , Hungary
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Nagykanizsa, , Hungary
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Orosháza, , Hungary
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Szentes, , Hungary
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Székesfehérvár, , Hungary
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Szobathely, , Hungary
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Gdansk, Pomeranian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Bialystok, , Poland
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Bialystok, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Zamość, , Poland
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Caguas, PR, Puerto Rico
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Carolina, PR, Puerto Rico
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Río Grande, PR, Puerto Rico
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Las Lomas, San Juan, Puerto Rico
Luis Rivera-Colon, Md
Las Lomas, San Juan, Puerto Rico
Fb Med Research, Psc
Caguas, , Puerto Rico
Policlinica Dr. Luis Rodriguez
Carolina, , Puerto Rico
Local Institution
Ponce, , Puerto Rico
Ponce School Of Medicine
Ponce, , Puerto Rico
Local Institution
Ponce, , Puerto Rico
Research & Cardiovascular Corp
Ponce, , Puerto Rico
Caparra Internal Med Res Ctr
Río Grande, , Puerto Rico
Altamira Family Medicine And Research Institute
San Juan, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
The Office Of Miguel Sosa-Padilla, Md
San Juan, , Puerto Rico
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Alba Iulia, , Romania
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Bacau, , Romania
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Bacau, , Romania
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Baia Mare, , Romania
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Brasov, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Ploieşti, , Romania
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Satu Mare, , Romania
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Tg Mures, , Romania
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Mthatha, Eastern Cape, South Africa
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Port Elizabeth, Eastern Cape, South Africa
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Welkom, Free State, South Africa
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Lyttelton, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Phoenix, Durban, KwaZulu-Natal, South Africa
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Brits, North West, South Africa
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Cape Town, Western Cape, South Africa
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Worcester, Western Cape, South Africa
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Potchefstroom, , South Africa
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Monifieth, AFO, United Kingdom
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Carmarthen, CAT, United Kingdom
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Fife, FIF, United Kingdom
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Chippenham, Wiltshire, United Kingdom
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Chippenham, WLT, United Kingdom
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Addlestone, , United Kingdom
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Bath, , United Kingdom
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Cardenden Fife, , United Kingdom
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Dundee, , United Kingdom
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Dundee, , United Kingdom
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Manchester, , United Kingdom
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Nuneaton, , United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS clinical trial educational resource
Investigator Inquiry form
FDA Safety Alerts and Recalls
Other Identifiers
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2012-004531-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV181-206
Identifier Type: -
Identifier Source: org_study_id
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