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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864174
• Other study ID #: CV181-206
• Secondary ID: 2012-004531-23
• Status: Completed
• Phase: Phase 4
• Start date: June 20, 2013
• Est. completion date: June 1, 2016

Study information

• Verified date: November 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1736
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Metformin XR

• Metformin IR

• Placebo matching with Metformin XR

• Placebo matching with Metformin IR

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Hungary,  Poland,  Puerto Rico,  Romania,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Primary	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
Secondary	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
Secondary	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

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form