Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes

NCT01864174 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CV181-2062012-004531-23
• Study Type: interventional
• Target: 1,736
• Locations: 10 countries
• Sites: 156

Brief Summary

The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Adjusted Mean Change From Baseline in HbA1c

  Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.

  Baseline and Week 24

• Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation

  SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.

  Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)

Secondary Outcomes (3)

• Mean Change in Fasting Plasma Glucose (FPG)

  Baseline and Week 24

• Mean Change in Mean Daily Glucose (MDG)

  Baseline and Week 24

• Percent of Participants With HbA1c < 7%

  Week 24

Study Arms (2)

Arm 1: Metformin XR and Placebo matching with Metformin XR

ACTIVE COMPARATOR

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

Drug: Metformin XR; Drug: Placebo matching with Metformin XR

Arm 2: Metformin IR and Placebo matching with Metformin IR

ACTIVE COMPARATOR

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

Drug: Metformin IR; Drug: Placebo matching with Metformin IR

Interventions

Metformin XR DRUG

Also known as: Glucophage XR

Arm 1: Metformin XR and Placebo matching with Metformin XR

Metformin IR DRUG

Also known as: Glucophage

Arm 2: Metformin IR and Placebo matching with Metformin IR

Placebo matching with Metformin XR DRUG

Arm 1: Metformin XR and Placebo matching with Metformin XR

Placebo matching with Metformin IR DRUG

Arm 2: Metformin IR and Placebo matching with Metformin IR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged ≥18 years old at time of enrollment
• 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

You may not qualify if:

• History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma
• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (156)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Terence T. Hart, Md

Muscle Shoals, Alabama, 35662, United States

Location

Clini Res Advantage Desert Clin Res, Llc

Mesa, Arizona, 85213, United States

Location

Clinical Res Advantage Central

Phoenix, Arkansas, 85020, United States

Location

Marin Endocrine Care And Research, Inc.

Greenbrae, California, 94904, United States

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Torrance Clinical Research Institute Inc.

Lomita, California, 90717, United States

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Actca

Los Angeles, California, 90017, United States

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National Research Institute

Los Angeles, California, 90057, United States

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R. Srinivasan, M.D., Inc.

Monterey Park, California, 91754, United States

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Diabetes Medical Center Of California

Northridge, California, 91325, United States

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Valley Clinical Trials

Northridge, California, 91325, United States

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Center For Clinical Trials Of Sacramento, Inc.

Sacramento, California, 95823, United States

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Clinical Research Advantage

Colorado Springs, Colorado, 80906, United States

Location

Clinical Research Advantage

Colorado Springs, Colorado, 80909, United States

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Colorado Springs Family Practice

Colorado Springs, Colorado, 80909, United States

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Clinical Research Advantage, Inc/Co Springs Health Partners, Briar

Colorado Springs, Colorado, 80920, United States

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Solutions Through Advanced Research, Inc.

Jacksonville, Florida, 32258, United States

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Family Care Partners

Jacksonville, Florida, 32277, United States

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Omega Research Consultants, Llc

Orlando, Florida, 32804, United States

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Palm Harbor Medical Associates

Palm Harbor, Florida, 34684, United States

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Gulfcoast Medical Research Center, Llc

Tampa, Florida, 33607, United States

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Cedar-Crosse Research Ctr

Chicago, Illinois, 60607, United States

Location

Clinical Research Advantage, Inc./Family Medicine Associates

Evansville, Indiana, 47725, United States

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American Health Network Of In Llc

Muncie, Indiana, 47304, United States

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Columbia Medical Practice

Columbia, Maryland, 21045, United States

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Centennial Medical Group

Elkridge, Maryland, 21075, United States

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Drs. Rodbard And Dempsey

Rockville, Maryland, 20852, United States

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Ny Clinical Trials

New York, New York, 10018, United States

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White Oak Family Physicians, Pa

Asheboro, North Carolina, 27203, United States

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Metrolina Internal Medicine

Charlotte, North Carolina, 28204, United States

Location

Medical Research Unlimited, Inc.

Cincinnati, Ohio, 45242, United States

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Lion Research

Norman, Oklahoma, 73069, United States

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Lynn Institute of Norman

Norman, Oklahoma, 73069, United States

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Integrated Medical Group Pc / Fleetwood Medical Assoc.

Fleetwood, Pennsylvania, 19522, United States

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Palmetto Clinical Trial Services Llc

Fountain Inn, South Carolina, 29644, United States

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Holston Medical Group

Bristol, Tennessee, 37620, United States

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Dallas Diabetes & Endocrine Center

Dallas, Texas, 75230, United States

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Covenant Clinical Research, Pa

San Antonio, Texas, 78229, United States

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Independence Family Medicine

Virginia Beach, Virginia, 23455, United States

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Local Institution

Edmonton, Alberta, T5A 4L8, Canada

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Winnipeg, Manitoba, R2V 4W3, Canada

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Brampton, Ontario, L6T 0G1, Canada

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Burlington, Ontario, L7M 4YI, Canada

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Collingwood, Ontario, L9Y 1W3, Canada

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London, Ontario, N6H 0G6, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Québec, Quebec, G1N 4V3, Canada

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London, N5W 6A2, Canada

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Brno, 636 00, Czechia

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České Budějovice, 370 01, Czechia

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Krnov, 794 01, Czechia

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Liberec, 460 01, Czechia

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Litomyšl, 570 14, Czechia

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Nový Jičín, 741 01, Czechia

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Ostrava-Kunčice, 719 00, Czechia

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Prague, 100 00, Czechia

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Prague, 11694, Czechia

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Prague, 15000, Czechia

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Aschaffenburg, Bavaria, 63739, Germany

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Münster, North Rhine-Westphalia, 48145, Germany

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Leipzig, Saxony, 04249, Germany

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Berlin, 12157, Germany

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Heidelberg, 69115, Germany

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Leipzig, Germany

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Löhne, 32584, Germany

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Myen, 56727, Germany

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Papenburg, D-26871, Germany

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Pirna, 01796, Germany

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Pécs, Baranya, 7623, Hungary

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Szigetvár, Baranya, 7900, Hungary

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Sátoraljaújhely, Borsod-Abauj Zemplen county, 3980, Hungary

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Hodmezvasarhely, Csongrád megye, 6800, Hungary

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Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

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Nyíregyháza, Szabolcs-Szatmár-Bereg, 4405, Hungary

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Budapest, 100036, Hungary

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Budapest, 1033, Hungary

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Budapest, 1083, Hungary

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Budapest, 1097, Hungary

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Budapest, 1183, Hungary

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Budapest, 1212, Hungary

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Csorna, 9300, Hungary

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Debrecen, 4025, Hungary

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Kecskemét, 6000, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Nagykanizsa, 8800, Hungary

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Orosháza, 5900, Hungary

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Szentes, 6600, Hungary

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Székesfehérvár, 8000, Hungary

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Szobathely, H-9700, Hungary

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Gdansk, Pomeranian Voivodeship, 80-546, Poland

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Katowice, Silesian Voivodeship, 40-752, Poland

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Bialystok, 15-276, Poland

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Bialystok, 15-435, Poland

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Krakow, 31-024, Poland

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Krakow, 31261, Poland

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Lublin, 20-090, Poland

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Lublin, 20-538, Poland

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Poznan, 61-655, Poland

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Zamość, Poland

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Caguas, PR, 00725, Puerto Rico

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Carolina, PR, 00983, Puerto Rico

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Río Grande, PR, 00745, Puerto Rico

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Las Lomas, San Juan, 00921, Puerto Rico

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Luis Rivera-Colon, Md

Las Lomas, San Juan, 00921, Puerto Rico

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Fb Med Research, Psc

Caguas, 00725, Puerto Rico

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Policlinica Dr. Luis Rodriguez

Carolina, 00983, Puerto Rico

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Local Institution

Ponce, 00716, Puerto Rico

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Ponce School Of Medicine

Ponce, 00716, Puerto Rico

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Local Institution

Ponce, 00717, Puerto Rico

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Research & Cardiovascular Corp

Ponce, 00717, Puerto Rico

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Caparra Internal Med Res Ctr

Río Grande, 00745, Puerto Rico

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Altamira Family Medicine And Research Institute

San Juan, 00920, Puerto Rico

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Local Institution

San Juan, 00920, Puerto Rico

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Local Institution

San Juan, 00926-2832, Puerto Rico

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The Office Of Miguel Sosa-Padilla, Md

San Juan, 00926, Puerto Rico

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Alba Iulia, 510053, Romania

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Bacau, 600114, Romania

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Bacau, 600164, Romania

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Baia Mare, 430123, Romania

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Brasov, 500283, Romania

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Brasov, 500365, Romania

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Bucharest, 010507, Romania

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Bucharest, 011234, Romania

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Bucharest, 014461, Romania

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Bucharest, 050538, Romania

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Bucharest, 050722, Romania

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Constanța, 900675, Romania

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Ploieşti, 100683, Romania

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Satu Mare, 440055, Romania

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Tg Mures, 540142, Romania

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Mthatha, Eastern Cape, 5099, South Africa

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Port Elizabeth, Eastern Cape, 6014, South Africa

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Welkom, Free State, 9460, South Africa

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Lyttelton, Gauteng, 0157, South Africa

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Pretoria, Gauteng, 0002, South Africa

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Pretoria, Gauteng, 0101, South Africa

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Durban, KwaZulu-Natal, 4091, South Africa

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Phoenix, Durban, KwaZulu-Natal, 4068, South Africa

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Brits, North West, 0250, South Africa

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Cape Town, Western Cape, 7460, South Africa

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Worcester, Western Cape, 6850, South Africa

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Potchefstroom, 2531, South Africa

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Monifieth, AFO, DD5 4LX, United Kingdom

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Carmarthen, CAT, SA31 2AF, United Kingdom

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Fife, FIF, KY14 7AW, United Kingdom

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Chippenham, Wiltshire, SN15 2SB, United Kingdom

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Chippenham, WLT, SN14 6GT, United Kingdom

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Addlestone, KT15 2BH, United Kingdom

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Bath, BA1 3NG, United Kingdom

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Cardenden Fife, KY5 0JE, United Kingdom

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Dundee, DD2 5NH, United Kingdom

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Dundee, DD4 6RD, United Kingdom

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Manchester, M23 9LT, United Kingdom

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Nuneaton, CV10 7DJ, United Kingdom

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Related Links

• BMS Clinical Trial Information
• BMS clinical trial educational resource
• Investigator Inquiry form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 29, 2013
• Study Start: June 20, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 29, 2019
• Results First Posted: July 21, 2017

Record last verified: 2019-11

Locations

PR (16); US (39); CZ (10); PL (10); RO (15); HU (21); DE (10); ZA (12); CA (11); GB (12)