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Type 2 Diabetes MellitusPhase 4NCT01864174

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

A Phase 4 study testing Metformin XR and Metformin IR in people with Type 2 Diabetes Mellitus, run by Bristol-Myers Squibb at 156 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Metformin XR and Metformin IR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,736 participants
Where
156 sitesin 10 countries
Study dates
20 Jun 2013to 1 Jun 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

156 sites in 10 countries.

156 sites in 10 countries

United States39 sites

  • White Oak Family Physicians, Pa

    Asheboro, North Carolina, 27203

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Metrolina Internal Medicine

    Charlotte, North Carolina, 28204

  • Cedar-Crosse Research Ctr

    Chicago, Illinois, 60607

  • Medical Research Unlimited, Inc.

    Cincinnati, Ohio, 45242

  • Clinical Research Advantage

    Colorado Springs, Colorado, 80906

  • Clinical Research Advantage

    Colorado Springs, Colorado, 80909

  • Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

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

    Colorado Springs, Colorado, 80920

  • Columbia Medical Practice

    Columbia, Maryland, 21045

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Clinical Research Advantage, Inc./Family Medicine Associates

    Evansville, Indiana, 47725

  • Integrated Medical Group Pc / Fleetwood Medical Assoc.

    Fleetwood, Pennsylvania, 19522

  • Palmetto Clinical Trial Services Llc

    Fountain Inn, South Carolina, 29644

  • Marin Endocrine Care And Research, Inc.

    Greenbrae, California, 94904

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32258

  • Family Care Partners

    Jacksonville, Florida, 32277

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717

  • Actca

    Los Angeles, California, 90017

  • National Research Institute

    Los Angeles, California, 90057

  • Clini Res Advantage Desert Clin Res, Llc

    Mesa, Arizona, 85213

  • R. Srinivasan, M.D., Inc.

    Monterey Park, California, 91754

  • American Health Network Of In Llc

    Muncie, Indiana, 47304

  • Terence T. Hart, Md

    Muscle Shoals, Alabama, 35662

  • Ny Clinical Trials

    New York, New York, 10018

  • Lion Research

    Norman, Oklahoma, 73069

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • Diabetes Medical Center Of California

    Northridge, California, 91325

  • Valley Clinical Trials

    Northridge, California, 91325

  • Omega Research Consultants, Llc

    Orlando, Florida, 32804

  • Palm Harbor Medical Associates

    Palm Harbor, Florida, 34684

  • Clinical Res Advantage Central

    Phoenix, Arkansas, 85020

  • Drs. Rodbard And Dempsey

    Rockville, Maryland, 20852

  • Center For Clinical Trials Of Sacramento, Inc.

    Sacramento, California, 95823

  • Covenant Clinical Research, Pa

    San Antonio, Texas, 78229

  • Gulfcoast Medical Research Center, Llc

    Tampa, Florida, 33607

  • Independence Family Medicine

    Virginia Beach, Virginia, 23455

Other trials in United States

Hungary21 sites

  • Local Institution

    Budapest, 100036

  • Local Institution

    Budapest, 1033

  • Local Institution

    Budapest, 1083

  • Local Institution

    Budapest, 1097

  • Local Institution

    Budapest, 1183

  • Local Institution

    Budapest, 1212

  • Local Institution

    Csorna, 9300

  • Local Institution

    Debrecen, 4025

  • Local Institution

    Hodmezvasarhely, Csongrád megye, 6800

  • Local Institution

    Kecskemét, 6000

  • Local Institution

    Mosonmagyaróvár, 9200

  • Local Institution

    Nagykanizsa, 8800

  • Local Institution

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Local Institution

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4405

  • Local Institution

    Orosháza, 5900

  • Local Institution

    Pécs, Baranya, 7623

  • Local Institution

    Sátoraljaújhely, Borsod-Abauj Zemplen county, 3980

  • Local Institution

    Székesfehérvár, 8000

  • Local Institution

    Szentes, 6600

  • Local Institution

    Szigetvár, Baranya, 7900

  • Local Institution

    Szobathely, H-9700

Other trials in Hungary

Puerto Rico16 sites

  • Local Institution

    Caguas, PR, 00725

  • Fb Med Research, Psc

    Caguas, 00725

  • Local Institution

    Carolina, PR, 00983

  • Policlinica Dr. Luis Rodriguez

    Carolina, 00983

  • Local Institution

    Las Lomas, San Juan, 00921

  • Luis Rivera-Colon, Md

    Las Lomas, San Juan, 00921

  • Local Institution

    Ponce, 00716

  • Ponce School Of Medicine

    Ponce, 00716

  • Local Institution

    Ponce, 00717

  • Research & Cardiovascular Corp

    Ponce, 00717

  • Local Institution

    Rio Grande, PR, 00745

  • Caparra Internal Med Res Ctr

    Rio Grande, 00745

  • Altamira Family Medicine And Research Institute

    San Juan, 00920

  • Local Institution

    San Juan, 00920

  • Local Institution

    San Juan, 00926-2832

  • The Office Of Miguel Sosa-Padilla, Md

    San Juan, 00926

Other trials in Puerto Rico

Romania15 sites

  • Local Institution

    Alba Iulia, 510053

  • Local Institution

    Bacau, 600114

  • Local Institution

    Bacau, 600164

  • Local Institution

    Baia Mare, 430123

  • Local Institution

    Brasov, 500283

  • Local Institution

    Brasov, 500365

  • Local Institution

    Bucharest, 010507

  • Local Institution

    Bucharest, 011234

  • Local Institution

    Bucharest, 014461

  • Local Institution

    Bucharest, 050538

  • Local Institution

    Bucharest, 050722

  • Local Institution

    Constanța, 900675

  • Local Institution

    Ploieşti, 100683

  • Local Institution

    Satu Mare, 440055

  • Local Institution

    Tg Mures, 540142

Other trials in Romania

South Africa12 sites

  • Local Institution

    Brits, North West, 0250

  • Local Institution

    Cape Town, Western Cape, 7460

  • Local Institution

    Durban, KwaZulu-Natal, 4091

  • Local Institution

    Lyttelton, Gauteng, 0157

  • Local Institution

    Mthatha, Eastern Cape, 5099

  • Local Institution

    Phoenix, Durban, KwaZulu-Natal, 4068

  • Local Institution

    Port Elizabeth, Eastern Cape, 6014

  • Local Institution

    Potchefstroom, 2531

  • Local Institution

    Pretoria, Gauteng, 0002

  • Local Institution

    Pretoria, Gauteng, 0101

  • Local Institution

    Welkom, Free State, 9460

  • Local Institution

    Worcester, Western Cape, 6850

Other trials in South Africa

United Kingdom12 sites

  • Local Institution

    Addlestone, KT15 2BH

  • Local Institution

    Bath, BA1 3NG

  • Local Institution

    Cardenden Fife, KY5 0JE

  • Local Institution

    Carmarthen, CAT, SA31 2AF

  • Local Institution

    Chippenham, Wiltshire, SN15 2SB

  • Local Institution

    Chippenham, WLT, SN14 6GT

  • Local Institution

    Dundee, DD2 5NH

  • Local Institution

    Dundee, DD4 6RD

  • Local Institution

    Fife, FIF, KY14 7AW

  • Local Institution

    Manchester, M23 9LT

  • Local Institution

    Monifieth, AFO, DD5 4LX

  • Local Institution

    Nuneaton, CV10 7DJ

Other trials in United Kingdom

Canada11 sites

  • Local Institution

    Brampton, Ontario, L6T 0G1

  • Local Institution

    Burlington, Ontario, L7M 4YI

  • Local Institution

    Collingwood, Ontario, L9Y 1W3

  • Local Institution

    Edmonton, Alberta, T5A 4L8

  • Local Institution

    London, Ontario, N6H 0G6

  • Local Institution

    London, N5W 6A2

  • Local Institution

    Newmarket, Ontario, L3Y 5G8

  • Local Institution

    Québec, Quebec, G1N 4V3

  • Local Institution

    Toronto, Ontario, M9V 4B4

  • Local Institution

    Toronto, Ontario, M9W 4L6

  • Local Institution

    Winnipeg, Manitoba, R2V 4W3

Other trials in Canada

Czechia10 sites

  • Local Institution

    Brno, 636 00

  • Local Institution

    České Budějovice, 370 01

  • Local Institution

    Krnov, 794 01

  • Local Institution

    Liberec, 460 01

  • Local Institution

    Litomyšl, 570 14

  • Local Institution

    Nový Jičín, 741 01

  • Local Institution

    Ostrava-Kunčice, 719 00

  • Local Institution

    Prague, 100 00

  • Local Institution

    Prague, 11694

  • Local Institution

    Prague, 15000

Other trials in Czechia

Germany10 sites

  • Local Institution

    Aschaffenburg, Bavaria, 63739

  • Local Institution

    Berlin, 12157

  • Local Institution

    Heidelberg, 69115

  • Local Institution

    Leipzig, Saxony, 04249

  • Local Institution

    Leipzig

  • Local Institution

    Löhne, 32584

  • Local Institution

    Münster, North Rhine-Westphalia, 48145

  • Local Institution

    Myen, 56727

  • Local Institution

    Papenburg, D-26871

  • Local Institution

    Pirna, 01796

Other trials in Germany

Poland10 sites

  • Local Institution

    Bialystok, 15-276

  • Local Institution

    Bialystok, 15-435

  • Local Institution

    Gdansk, Pomeranian Voivodeship, 80-546

  • Local Institution

    Katowice, Silesian Voivodeship, 40-752

  • Local Institution

    Krakow, 31-024

  • Local Institution

    Krakow, 31261

  • Local Institution

    Lublin, 20-090

  • Local Institution

    Lublin, 20-538

  • Local Institution

    Poznan, 61-655

  • Local Institution

    Zamość

Other trials in Poland

About this study

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

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

Being tested
Metformin XR, Metformin IR, Placebo matching with Metformin XR, Placebo matching with Metformin IR
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin XRDrug

    Also called Glucophage XR

  • Metformin IRDrug

    Also called Glucophage

  • Placebo matching with Metformin XRDrug

  • Placebo matching with Metformin IRDrug

Study groups in NCT01864174
Study groupRoleWhat they receive
Arm 1: Metformin XR and Placebo matching with Metformin XRActive comparatorMetformin 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
Receives: Drug: Metformin XR; Drug: Placebo matching with Metformin XR
Arm 2: Metformin IR and Placebo matching with Metformin IRActive comparatorMetformin 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
Receives: Drug: Metformin IR; Drug: Placebo matching with Metformin IR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adjusted Mean Change From Baseline in HbA1c

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

    Measured: Baseline and Week 24

  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

    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.

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

Secondary outcomes (3)

  1. 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

    Measured: Baseline and Week 24

  2. 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.

    Measured: Baseline and Week 24

  3. 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.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study start20 Jun 2013
  3. Primary completion1 Jun 2016
  4. Study completion1 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01864174
Sponsor's protocol ID
CV181-206
Other IDs
2012-004531-23
Status last verified
Nov 2019
First submitted
24 May 2013
Last updated
29 Nov 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin XR and Metformin IR in people with Type 2 Diabetes Mellitus, run by Bristol-Myers Squibb at 156 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Hungary, Puerto Rico, Romania, South Africa and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in HbA1c (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01864174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.

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