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

November 26, 2019 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1736

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Glucophage
Drug: Placebo matching with Metformin IR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and Week 24
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.
Baseline and Week 24
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.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV181-206
  • 2012-004531-23 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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