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

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ClinicalTrials.gov Identifier: NCT01864174
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : July 21, 2017
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Metformin XR Drug: Metformin IR Drug: Placebo matching with Metformin XR Drug: Placebo matching with Metformin IR Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adults Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Actual Study Start Date : June 20, 2013
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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

Drug: Metformin XR
Other Name: Glucophage XR

Drug: Placebo matching with Metformin XR
Active Comparator: 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

Drug: Metformin IR
Other Name: Glucophage

Drug: Placebo matching with Metformin IR



Primary Outcome Measures :
  1. Adjusted Mean Change From Baseline in HbA1c [ Time Frame: Baseline and Week 24 ]
    Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.

  2. 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 [ Time Frame: Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks) ]
    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.


Secondary Outcome Measures :
  1. Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 24 ]
    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

  2. Mean Change in Mean Daily Glucose (MDG) [ Time Frame: Baseline and Week 24 ]
    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.

  3. Percent of Participants With HbA1c < 7% [ Time Frame: Week 24 ]
    Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864174


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Locations
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United States, Alabama
Central Alabama Research
Birmingham, Alabama, United States, 35209
Terence T. Hart, Md
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Clini Res Advantage Desert Clin Res, Llc
Mesa, Arizona, United States, 85213
United States, Arkansas
Clinical Res Advantage Central
Phoenix, Arkansas, United States, 85020
United States, California
Marin Endocrine Care And Research, Inc.
Greenbrae, California, United States, 94904
Torrance Clinical Research Institute Inc.
Lomita, California, United States, 90717
Actca
Los Angeles, California, United States, 90017
National Research Institute
Los Angeles, California, United States, 90057
R. Srinivasan, M.D., Inc.
Monterey Park, California, United States, 91754
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Valley Clinical Trials
Northridge, California, United States, 91325
Center For Clinical Trials Of Sacramento, Inc.
Sacramento, California, United States, 95823
United States, Colorado
Clinical Research Advantage
Colorado Springs, Colorado, United States, 80906
Clinical Research Advantage
Colorado Springs, Colorado, United States, 80909
Colorado Springs Family Practice
Colorado Springs, Colorado, United States, 80909
Clinical Research Advantage, Inc/Co Springs Health Partners, Briar
Colorado Springs, Colorado, United States, 80920
United States, Florida
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States, 32258
Family Care Partners
Jacksonville, Florida, United States, 32277
Omega Research Consultants, Llc
Orlando, Florida, United States, 32804
Palm Harbor Medical Associates
Palm Harbor, Florida, United States, 34684
Gulfcoast Medical Research Center, Llc
Tampa, Florida, United States, 33607
United States, Illinois
Cedar-Crosse Research Ctr
Chicago, Illinois, United States, 60607
United States, Indiana
Clinical Research Advantage, Inc./Family Medicine Associates
Evansville, Indiana, United States, 47725
American Health Network Of In Llc
Muncie, Indiana, United States, 47304
United States, Maryland
Columbia Medical Practice
Columbia, Maryland, United States, 21045
Centennial Medical Group
Elkridge, Maryland, United States, 21075
Drs. Rodbard And Dempsey
Rockville, Maryland, United States, 20852
United States, New York
Ny Clinical Trials
New York, New York, United States, 10018
United States, North Carolina
White Oak Family Physicians, Pa
Asheboro, North Carolina, United States, 27203
Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
United States, Ohio
Medical Research Unlimited, Inc.
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Lion Research
Norman, Oklahoma, United States, 73069
Lynn Institute of Norman
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Integrated Medical Group Pc / Fleetwood Medical Assoc.
Fleetwood, Pennsylvania, United States, 19522
United States, South Carolina
Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina, United States, 29644
United States, Tennessee
Holston Medical Group
Bristol, Tennessee, United States, 37620
United States, Texas
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
Covenant Clinical Research, Pa
San Antonio, Texas, United States, 78229
United States, Virginia
Independence Family Medicine
Virginia Beach, Virginia, United States, 23455
Canada, Alberta
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Edmonton, Alberta, Canada, T5A 4L8
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2V 4W3
Canada, Ontario
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Brampton, Ontario, Canada, L6T 0G1
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Burlington, Ontario, Canada, L7M 4YI
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Collingwood, Ontario, Canada, L9Y 1W3
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London, Ontario, Canada, N6H 0G6
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Newmarket, Ontario, Canada, L3Y 5G8
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Toronto, Ontario, Canada, M9V 4B4
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Toronto, Ontario, Canada, M9W 4L6
Canada
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London, Canada, N5W 6A2
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Quebec, Canada, G1N 4V3
Czechia
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Brno, Czechia, 636 00
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Ceske Budejovice, Czechia, 370 01
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Krnov, Czechia, 794 01
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Liberec, Czechia, 460 01
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Litomysl, Czechia, 570 14
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Novy Jicin, Czechia, 741 01
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Ostrava - Kuncice, Czechia, 719 00
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Praha 10, Czechia, 100 00
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Praha 1, Czechia, 11694
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Praha 5, Czechia, 15000
Germany
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Aschaffenburg, Bayern, Germany, 63739
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Munster, Nordrhein-Westfalen, Germany, 48145
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Leipzig, Saxony, Germany, 04249
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Berlin, Germany, 12157
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Heidelberg, Germany, 69115
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Leipzig, Germany
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Lohne, Germany, 32584
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Myen, Germany, 56727
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Papenburg, Germany, D-26871
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Pirna, Germany, 01796
Hungary
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Pecs, Baranya, Hungary, 7623
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Szigetvar, Baranya, Hungary, 7900
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Satoraljaujhely, Borsod-Abauj-Zemplen, Hungary, 3980
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Hodmezvasarhely, Csongrad, Hungary, 6800
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Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
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Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4405
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Budapest, Hungary, 100036
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Budapest, Hungary, 1033
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Budapest, Hungary, 1083
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Budapest, Hungary, 1097
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Budapest, Hungary, 1183
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Budapest, Hungary, 1212
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Csorna, Hungary, 9300
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Debrecen, Hungary, 4025
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Kecskemet, Hungary, 6000
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Mosonmagyarovar, Hungary, 9200
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Nagykanizsa, Hungary, 8800
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Oroshaza, Hungary, 5900
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Szekesfehervar, Hungary, 8000
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Szentes, Hungary, 6600
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Szobathely, Hungary, H-9700
Poland
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Gdansk, Pomorskie, Poland, 80-546
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Katowice, Slaskie, Poland, 40-752
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Bialystok, Poland, 15-276
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Bialystok, Poland, 15-435
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Krakow, Poland, 31-024
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Krakow, Poland, 31261
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Lublin, Poland, 20-090
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Lublin, Poland, 20-538
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Poznan, Poland, 61-655
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Zamosc, Poland
Puerto Rico
Fb Med Research, Psc
Caguas, Puerto Rico, 00725
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Caguas, Puerto Rico, 00725
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Carolina, Puerto Rico, 00983
Policlinica Dr. Luis Rodriguez
Carolina, Puerto Rico, 00983
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Las Lomas, Puerto Rico, 00921
Luis Rivera-Colon, Md
Las Lomas, Puerto Rico, 00921
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Ponce, Puerto Rico, 00716
Ponce School Of Medicine
Ponce, Puerto Rico, 00716
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Ponce, Puerto Rico, 00717
Research & Cardiovascular Corp
Ponce, Puerto Rico, 00717
Caparra Internal Med Res Ctr
Rio Grande, Puerto Rico, 00745
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Rio Grande, Puerto Rico, 00745
Altamira Family Medicine And Research Institute
San Juan, Puerto Rico, 00920
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San Juan, Puerto Rico, 00920
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San Juan, Puerto Rico, 00926-2832
The Office Of Miguel Sosa-Padilla, Md
San Juan, Puerto Rico, 00926
Romania
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Alba Iulia, Romania, 510053
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Bacau, Romania, 600114
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Bacau, Romania, 600164
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Baia Mare, Romania, 430123
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Brasov, Romania, 500283
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Brasov, Romania, 500365
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Bucharest, Romania, 011234
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Bucuresti, Romania, 010507
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Bucuresti, Romania, 014461
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Bucuresti, Romania, 050538
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Bucuresti, Romania, 050722
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Constanta, Romania, 900675
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Ploiesti, Romania, 100683
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Satu Mare, Romania, 440055
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Tg Mures, Romania, 540142
South Africa
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Mthatha, Eastern CAPE, South Africa, 5099
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Port Elizabeth, Eastern CAPE, South Africa, 6014
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Welkom, FREE State, South Africa, 9460
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Lyttelton, Gauteng, South Africa, 0157
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Pretoria, Gauteng, South Africa, 0002
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Pretoria, Gauteng, South Africa, 0101
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Durban, Kwazulu-Natal, South Africa, 4091
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Phoenix, Durban, Kwazulu-Natal, South Africa, 4068
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Brits, North-West, South Africa, 0250
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Cape Town, Western CAPE, South Africa, 7460
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Worcester, Western CAPE, South Africa, 6850
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Potchefstroom, South Africa, 2531
United Kingdom
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Monifieth, AFO, United Kingdom, DD5 4LX
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Carmarthen, CAT, United Kingdom, SA31 2AF
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Fife, FIF, United Kingdom, KY14 7AW
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Chippenham, Wiltshire, United Kingdom, SN15 2SB
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Chippenham, WLT, United Kingdom, SN14 6GT
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Addlestone, United Kingdom, KT15 2BH
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Bath, United Kingdom, BA1 3NG
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Cardenden Fife, United Kingdom, KY5 0JE
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Dundee, United Kingdom, DD2 5NH
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Dundee, United Kingdom, DD4 6RD
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Manchester, United Kingdom, M23 9LT
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Nuneaton, United Kingdom, CV10 7DJ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01864174     History of Changes
Other Study ID Numbers: CV181-206
2012-004531-23 ( EudraCT Number )
First Posted: May 29, 2013    Key Record Dates
Results First Posted: July 21, 2017
Last Update Posted: November 28, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs