Clinical trial NCT01864174: Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 1736
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Adjusted Mean Change From Baseline in HbA1c
timeFrame: Baseline and Week 24
measure: 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
timeFrame: Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)
Secondary outcomes:
measure: Mean Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline and Week 24
measure: Mean Change in Mean Daily Glucose (MDG)
timeFrame: Baseline and Week 24
measure: Percent of Participants With HbA1c < 7%
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Muscle Shoals
country: United States
facility: Terence T. Hart, Md
state: Alabama
city: Mesa
country: United States
facility: Clini Res Advantage Desert Clin Res, Llc
state: Arizona
city: Phoenix
country: United States
facility: Clinical Res Advantage Central
state: Arkansas
city: Greenbrae
country: United States
facility: Marin Endocrine Care And Research, Inc.
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: Los Angeles
country: United States
facility: Actca
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Monterey Park
country: United States
facility: R. Srinivasan, M.D., Inc.
state: California
city: Northridge
country: United States
facility: Diabetes Medical Center Of California
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Sacramento
country: United States
facility: Center For Clinical Trials Of Sacramento, Inc.
state: California
city: Colorado Springs
country: United States
facility: Clinical Research Advantage
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Advantage
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Family Practice
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Advantage, Inc/Co Springs Health Partners, Briar
state: Colorado
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Family Care Partners
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants, Llc
state: Florida
city: Palm Harbor
country: United States
facility: Palm Harbor Medical Associates
state: Florida
city: Tampa
country: United States
facility: Gulfcoast Medical Research Center, Llc
state: Florida
city: Chicago
country: United States
facility: Cedar-Crosse Research Ctr
state: Illinois
city: Evansville
country: United States
facility: Clinical Research Advantage, Inc./Family Medicine Associates
state: Indiana
city: Muncie
country: United States
facility: American Health Network Of In Llc
state: Indiana
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rockville
country: United States
facility: Drs. Rodbard And Dempsey
state: Maryland
city: New York
country: United States
facility: Ny Clinical Trials
state: New York
city: Asheboro
country: United States
facility: White Oak Family Physicians, Pa
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Internal Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Medical Research Unlimited, Inc.
state: Ohio
city: Norman
country: United States
facility: Lion Research
state: Oklahoma
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Fleetwood
country: United States
facility: Integrated Medical Group Pc / Fleetwood Medical Assoc.
state: Pennsylvania
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services Llc
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Covenant Clinical Research, Pa
state: Texas
city: Virginia Beach
country: United States
facility: Independence Family Medicine
state: Virginia
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Burlington
country: Canada
facility: Local Institution
state: Ontario
city: Collingwood
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Newmarket
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
city: Quebec
country: Canada
facility: Local Institution
city: Brno
country: Czechia
facility: Local Institution
city: Ceske Budejovice
country: Czechia
facility: Local Institution
city: Krnov
country: Czechia
facility: Local Institution
city: Liberec
country: Czechia
facility: Local Institution
city: Litomysl
country: Czechia
facility: Local Institution
city: Novy Jicin
country: Czechia
facility: Local Institution
city: Ostrava - Kuncice
country: Czechia
facility: Local Institution
city: Praha 10
country: Czechia
facility: Local Institution
city: Praha 1
country: Czechia
facility: Local Institution
city: Praha 5
country: Czechia
facility: Local Institution
city: Aschaffenburg
country: Germany
facility: Local Institution
state: Bayern
city: Munster
country: Germany
facility: Local Institution
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Local Institution
state: Saxony
city: Berlin
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Lohne
country: Germany
facility: Local Institution
city: Myen
country: Germany
facility: Local Institution
city: Papenburg
country: Germany
facility: Local Institution
city: Pirna
country: Germany
facility: Local Institution
city: Pecs
country: Hungary
facility: Local Institution
state: Baranya
city: Szigetvar
country: Hungary
facility: Local Institution
state: Baranya
city: Satoraljaujhely
country: Hungary
facility: Local Institution
state: Borsod-Abauj-Zemplen
city: Hodmezvasarhely
country: Hungary
facility: Local Institution
state: Csongrad
city: Nyiregyhaza
country: Hungary
facility: Local Institution
state: Szabolcs-Szatmar-Bereg
city: Nyiregyhaza
country: Hungary
facility: Local Institution
state: Szabolcs-Szatmar-Bereg
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Csorna
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Kecskemet
country: Hungary
facility: Local Institution
city: Mosonmagyarovar
country: Hungary
facility: Local Institution
city: Nagykanizsa
country: Hungary
facility: Local Institution
city: Oroshaza
country: Hungary
facility: Local Institution
city: Szekesfehervar
country: Hungary
facility: Local Institution
city: Szentes
country: Hungary
facility: Local Institution
city: Szobathely
country: Hungary
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
state: Pomorskie
city: Katowice
country: Poland
facility: Local Institution
state: Slaskie
city: Bialystok
country: Poland
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Zamosc
country: Poland
facility: Local Institution
city: Caguas
country: Puerto Rico
facility: Fb Med Research, Psc
city: Caguas
country: Puerto Rico
facility: Local Institution
city: Carolina
country: Puerto Rico
facility: Local Institution
city: Carolina
country: Puerto Rico
facility: Policlinica Dr. Luis Rodriguez
city: Las Lomas
country: Puerto Rico
facility: Local Institution
city: Las Lomas
country: Puerto Rico
facility: Luis Rivera-Colon, Md
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Ponce School Of Medicine
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Research & Cardiovascular Corp
city: Rio Grande
country: Puerto Rico
facility: Caparra Internal Med Res Ctr
city: Rio Grande
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Altamira Family Medicine And Research Institute
city: San Juan
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: The Office Of Miguel Sosa-Padilla, Md
city: Alba Iulia
country: Romania
facility: Local Institution
city: Bacau
country: Romania
facility: Local Institution
city: Bacau
country: Romania
facility: Local Institution
city: Baia Mare
country: Romania
facility: Local Institution
city: Brasov
country: Romania
facility: Local Institution
city: Brasov
country: Romania
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Constanta
country: Romania
facility: Local Institution
city: Ploiesti
country: Romania
facility: Local Institution
city: Satu Mare
country: Romania
facility: Local Institution
city: Tg Mures
country: Romania
facility: Local Institution
city: Mthatha
country: South Africa
facility: Local Institution
state: Eastern CAPE
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern CAPE
city: Welkom
country: South Africa
facility: Local Institution
state: FREE State
city: Lyttelton
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwazulu-Natal
city: Phoenix, Durban
country: South Africa
facility: Local Institution
state: Kwazulu-Natal
city: Brits
country: South Africa
facility: Local Institution
state: North-West
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Worcester
country: South Africa
facility: Local Institution
state: Western CAPE
city: Potchefstroom
country: South Africa
facility: Local Institution
city: Monifieth
country: United Kingdom
facility: Local Institution
state: AFO
city: Carmarthen
country: United Kingdom
facility: Local Institution
state: CAT
city: Fife
country: United Kingdom
facility: Local Institution
state: FIF
city: Chippenham
country: United Kingdom
facility: Local Institution
state: Wiltshire
city: Chippenham
country: United Kingdom
facility: Local Institution
state: WLT
city: Addlestone
country: United Kingdom
facility: Local Institution
city: Bath
country: United Kingdom
facility: Local Institution
city: Cardenden Fife
country: United Kingdom
facility: Local Institution
city: Dundee
country: United Kingdom
facility: Local Institution
city: Dundee
country: United Kingdom
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
city: Nuneaton
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: