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Clinical Trial Details

Trial ID: L2394
Source ID: NCT01864174
Associated Drug: Metformin Xr
Title: Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01864174/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Metformin XR|DRUG: Metformin IR|DRUG: Placebo matching with Metformin XR|DRUG: Placebo matching with Metformin IR
Outcome Measures: Primary: 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: Mean Change in Fasting Plasma Glucose (FPG), The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG \> 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter, Baseline and Week 24|Mean Change in Mean Daily Glucose (MDG), The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG., Baseline and Week 24|Percent of Participants With HbA1c < 7%, Percent of participants achieving a therapeutic glycemic response (defined as HbA1c \< 7.0%) at Week 24 in the double-blind treatment period., Week 24
Sponsor/Collaborators: Sponsor: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1736
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-06-20
Completion Date: 2016-06-01
Results First Posted: 2017-07-21
Last Update Posted: 2019-11-29
Locations: Central Alabama Research, Birmingham, Alabama, 35209, United States|Terence T. Hart, Md, Muscle Shoals, Alabama, 35662, United States|Clini Res Advantage Desert Clin Res, Llc, Mesa, Arizona, 85213, United States|Clinical Res Advantage Central, Phoenix, Arkansas, 85020, United States|Marin Endocrine Care And Research, Inc., Greenbrae, California, 94904, United States|Torrance Clinical Research Institute Inc., Lomita, California, 90717, United States|Actca, Los Angeles, California, 90017, United States|National Research Institute, Los Angeles, California, 90057, United States|R. Srinivasan, M.D., Inc., Monterey Park, California, 91754, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Valley Clinical Trials, Northridge, California, 91325, United States|Center For Clinical Trials Of Sacramento, Inc., Sacramento, California, 95823, United States|Clinical Research Advantage, Colorado Springs, Colorado, 80906, United States|Clinical Research Advantage, Colorado Springs, Colorado, 80909, United States|Colorado Springs Family Practice, Colorado Springs, Colorado, 80909, United States|Clinical Research Advantage, Inc/Co Springs Health Partners, Briar, Colorado Springs, Colorado, 80920, United States|Solutions Through Advanced Research, Inc., Jacksonville, Florida, 32258, United States|Family Care Partners, Jacksonville, Florida, 32277, United States|Omega Research Consultants, Llc, Orlando, Florida, 32804, United States|Palm Harbor Medical Associates, Palm Harbor, Florida, 34684, United States|Gulfcoast Medical Research Center, Llc, Tampa, Florida, 33607, United States|Cedar-Crosse Research Ctr, Chicago, Illinois, 60607, United States|Clinical Research Advantage, Inc./Family Medicine Associates, Evansville, Indiana, 47725, United States|American Health Network Of In Llc, Muncie, Indiana, 47304, United States|Columbia Medical Practice, Columbia, Maryland, 21045, United States|Centennial Medical Group, Elkridge, Maryland, 21075, United States|Drs. Rodbard And Dempsey, Rockville, Maryland, 20852, United States|Ny Clinical Trials, New York, New York, 10018, United States|White Oak Family Physicians, Pa, Asheboro, North Carolina, 27203, United States|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|Medical Research Unlimited, Inc., Cincinnati, Ohio, 45242, United States|Lion Research, Norman, Oklahoma, 73069, United States|Lynn Institute of Norman, Norman, Oklahoma, 73069, United States|Integrated Medical Group Pc / Fleetwood Medical Assoc., Fleetwood, Pennsylvania, 19522, United States|Palmetto Clinical Trial Services Llc, Fountain Inn, South Carolina, 29644, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|Covenant Clinical Research, Pa, San Antonio, Texas, 78229, United States|Independence Family Medicine, Virginia Beach, Virginia, 23455, United States|Local Institution, Edmonton, Alberta, T5A 4L8, Canada|Local Institution, Winnipeg, Manitoba, R2V 4W3, Canada|Local Institution, Brampton, Ontario, L6T 0G1, Canada|Local Institution, Burlington, Ontario, L7M 4YI, Canada|Local Institution, Collingwood, Ontario, L9Y 1W3, Canada|Local Institution, London, Ontario, N6H 0G6, Canada|Local Institution, Newmarket, Ontario, L3Y 5G8, Canada|Local Institution, Toronto, Ontario, M9V 4B4, Canada|Local Institution, Toronto, Ontario, M9W 4L6, Canada|Local Institution, London, N5W 6A2, Canada|Local Institution, Quebec, G1N 4V3, Canada|Local Institution, Brno, 636 00, Czechia|Local Institution, Ceske Budejovice, 370 01, Czechia|Local Institution, Krnov, 794 01, Czechia|Local Institution, Liberec, 460 01, Czechia|Local Institution, Litomysl, 570 14, Czechia|Local Institution, Novy Jicin, 741 01, Czechia|Local Institution, Ostrava - Kuncice, 719 00, Czechia|Local Institution, Praha 10, 100 00, Czechia|Local Institution, Praha 1, 11694, Czechia|Local Institution, Praha 5, 15000, Czechia|Local Institution, Aschaffenburg, Bayern, 63739, Germany|Local Institution, Munster, Nordrhein-Westfalen, 48145, Germany|Local Institution, Leipzig, Saxony, 04249, Germany|Local Institution, Berlin, 12157, Germany|Local Institution, Heidelberg, 69115, Germany|Local Institution, Leipzig, Germany|Local Institution, Lohne, 32584, Germany|Local Institution, Myen, 56727, Germany|Local Institution, Papenburg, D-26871, Germany|Local Institution, Pirna, 01796, Germany|Local Institution, Pecs, Baranya, 7623, Hungary|Local Institution, Szigetvar, Baranya, 7900, Hungary|Local Institution, Satoraljaujhely, Borsod-Abauj-Zemplen, 3980, Hungary|Local Institution, Hodmezvasarhely, Csongrad, 6800, Hungary|Local Institution, Nyiregyhaza, Szabolcs-Szatmar-Bereg, 4400, Hungary|Local Institution, Nyiregyhaza, Szabolcs-Szatmar-Bereg, 4405, Hungary|Local Institution, Budapest, 100036, Hungary|Local Institution, Budapest, 1033, Hungary|Local Institution, Budapest, 1083, Hungary|Local Institution, Budapest, 1097, Hungary|Local Institution, Budapest, 1183, Hungary|Local Institution, Budapest, 1212, Hungary|Local Institution, Csorna, 9300, Hungary|Local Institution, Debrecen, 4025, Hungary|Local Institution, Kecskemet, 6000, Hungary|Local Institution, Mosonmagyarovar, 9200, Hungary|Local Institution, Nagykanizsa, 8800, Hungary|Local Institution, Oroshaza, 5900, Hungary|Local Institution, Szekesfehervar, 8000, Hungary|Local Institution, Szentes, 6600, Hungary|Local Institution, Szobathely, H-9700, Hungary|Local Institution, Gdansk, Pomorskie, 80-546, Poland|Local Institution, Katowice, Slaskie, 40-752, Poland|Local Institution, Bialystok, 15-276, Poland|Local Institution, Bialystok, 15-435, Poland|Local Institution, Krakow, 31-024, Poland|Local Institution, Krakow, 31261, Poland|Local Institution, Lublin, 20-090, Poland|Local Institution, Lublin, 20-538, Poland|Local Institution, Poznan, 61-655, Poland|Local Institution, Zamosc, Poland|Fb Med Research, Psc, Caguas, 00725, Puerto Rico|Local Institution, Caguas, 00725, Puerto Rico|Local Institution, Carolina, 00983, Puerto Rico|Policlinica Dr. Luis Rodriguez, Carolina, 00983, Puerto Rico|Local Institution, Las Lomas, 00921, Puerto Rico|Luis Rivera-Colon, Md, Las Lomas, 00921, Puerto Rico|Local Institution, Ponce, 00716, Puerto Rico|Ponce School Of Medicine, Ponce, 00716, Puerto Rico|Local Institution, Ponce, 00717, Puerto Rico|Research & Cardiovascular Corp, Ponce, 00717, Puerto Rico|Caparra Internal Med Res Ctr, Rio Grande, 00745, Puerto Rico|Local Institution, Rio Grande, 00745, Puerto Rico|Altamira Family Medicine And Research Institute, San Juan, 00920, Puerto Rico|Local Institution, San Juan, 00920, Puerto Rico|Local Institution, San Juan, 00926-2832, Puerto Rico|The Office Of Miguel Sosa-Padilla, Md, San Juan, 00926, Puerto Rico|Local Institution, Alba Iulia, 510053, Romania|Local Institution, Bacau, 600114, Romania|Local Institution, Bacau, 600164, Romania|Local Institution, Baia Mare, 430123, Romania|Local Institution, Brasov, 500283, Romania|Local Institution, Brasov, 500365, Romania|Local Institution, Bucharest, 011234, Romania|Local Institution, Bucuresti, 010507, Romania|Local Institution, Bucuresti, 014461, Romania|Local Institution, Bucuresti, 050538, Romania|Local Institution, Bucuresti, 050722, Romania|Local Institution, Constanta, 900675, Romania|Local Institution, Ploiesti, 100683, Romania|Local Institution, Satu Mare, 440055, Romania|Local Institution, Tg Mures, 540142, Romania|Local Institution, Mthatha, Eastern CAPE, 5099, South Africa|Local Institution, Port Elizabeth, Eastern CAPE, 6014, South Africa|Local Institution, Welkom, FREE State, 9460, South Africa|Local Institution, Lyttelton, Gauteng, 0157, South Africa|Local Institution, Pretoria, Gauteng, 0002, South Africa|Local Institution, Pretoria, Gauteng, 0101, South Africa|Local Institution, Durban, Kwazulu-Natal, 4091, South Africa|Local Institution, Phoenix, Durban, Kwazulu-Natal, 4068, South Africa|Local Institution, Brits, North-West, 0250, South Africa|Local Institution, Cape Town, Western CAPE, 7460, South Africa|Local Institution, Worcester, Western CAPE, 6850, South Africa|Local Institution, Potchefstroom, 2531, South Africa|Local Institution, Monifieth, AFO, DD5 4LX, United Kingdom|Local Institution, Carmarthen, CAT, SA31 2AF, United Kingdom|Local Institution, Fife, FIF, KY14 7AW, United Kingdom|Local Institution, Chippenham, Wiltshire, SN15 2SB, United Kingdom|Local Institution, Chippenham, WLT, SN14 6GT, United Kingdom|Local Institution, Addlestone, KT15 2BH, United Kingdom|Local Institution, Bath, BA1 3NG, United Kingdom|Local Institution, Cardenden Fife, KY5 0JE, United Kingdom|Local Institution, Dundee, DD2 5NH, United Kingdom|Local Institution, Dundee, DD4 6RD, United Kingdom|Local Institution, Manchester, M23 9LT, United Kingdom|Local Institution, Nuneaton, CV10 7DJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01864174

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details