Back to resultsPhase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Metformin XR
Metformin IR
Placebo matching with Metformin XR
Placebo matching with Metformin IR
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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)
Sites / Locations
- Central Alabama Research
- Terence T. Hart, Md
- Clini Res Advantage Desert Clin Res, Llc
- Clinical Res Advantage Central
- Marin Endocrine Care And Research, Inc.
- Torrance Clinical Research Institute Inc.
- Actca
- National Research Institute
- R. Srinivasan, M.D., Inc.
- Diabetes Medical Center Of California
- Valley Clinical Trials
- Center For Clinical Trials Of Sacramento, Inc.
- Clinical Research Advantage
- Clinical Research Advantage
- Colorado Springs Family Practice
- Clinical Research Advantage, Inc/Co Springs Health Partners, Briar
- Solutions Through Advanced Research, Inc.
- Family Care Partners
- Omega Research Consultants, Llc
- Palm Harbor Medical Associates
- Gulfcoast Medical Research Center, Llc
- Cedar-Crosse Research Ctr
- Clinical Research Advantage, Inc./Family Medicine Associates
- American Health Network Of In Llc
- Columbia Medical Practice
- Centennial Medical Group
- Drs. Rodbard And Dempsey
- Ny Clinical Trials
- White Oak Family Physicians, Pa
- Metrolina Internal Medicine
- Medical Research Unlimited, Inc.
- Lion Research
- Lynn Institute of Norman
- Integrated Medical Group Pc / Fleetwood Medical Assoc.
- Palmetto Clinical Trial Services Llc
- Holston Medical Group
- Dallas Diabetes & Endocrine Center
- Covenant Clinical Research, Pa
- Independence Family Medicine
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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- Local Institution
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- Local Institution
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- Fb Med Research, Psc
- Local Institution
- Local Institution
- Policlinica Dr. Luis Rodriguez
- Local Institution
- Luis Rivera-Colon, Md
- Local Institution
- Ponce School Of Medicine
- Local Institution
- Research & Cardiovascular Corp
- Caparra Internal Med Res Ctr
- Local Institution
- Altamira Family Medicine And Research Institute
- Local Institution
- Local Institution
- The Office Of Miguel Sosa-Padilla, Md
- Local Institution
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1: Metformin XR and Placebo matching with Metformin XR
Arm 2: Metformin IR and Placebo matching with Metformin IR
Arm Description
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
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
Outcomes
Primary Outcome Measures
Adjusted Mean Change From Baseline in HbA1c
Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.
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.
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01864174
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2013 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1736 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Metformin XR and Placebo matching with Metformin XR
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm 2: Metformin IR and Placebo matching with Metformin IR
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Metformin XR
Other Intervention Name(s)
Glucophage XR
Intervention Type
Drug
Intervention Name(s)
Metformin IR
Other Intervention Name(s)
Glucophage
Intervention Type
Drug
Intervention Name(s)
Placebo matching with Metformin XR
Intervention Type
Drug
Intervention Name(s)
Placebo matching with Metformin IR
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in HbA1c
Description
Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.
Time Frame
Baseline and Week 24
Title
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
Description
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.
Time Frame
Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)
Secondary Outcome Measure Information:
Title
Mean Change in Fasting Plasma Glucose (FPG)
Description
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
Time Frame
Baseline and Week 24
Title
Mean Change in Mean Daily Glucose (MDG)
Description
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.
Time Frame
Baseline and Week 24
Title
Percent of Participants With HbA1c < 7%
Description
Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Terence T. Hart, Md
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
Clini Res Advantage Desert Clin Res, Llc
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Clinical Res Advantage Central
City
Phoenix
State/Province
Arkansas
ZIP/Postal Code
85020
Country
United States
Facility Name
Marin Endocrine Care And Research, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Actca
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
R. Srinivasan, M.D., Inc.
City
Monterey Park
State/Province
California
ZIP/Postal Code
91754
Country
United States
Facility Name
Diabetes Medical Center Of California
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Valley Clinical Trials
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Center For Clinical Trials Of Sacramento, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Clinical Research Advantage
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Clinical Research Advantage
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Colorado Springs Family Practice
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Clinical Research Advantage, Inc/Co Springs Health Partners, Briar
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Solutions Through Advanced Research, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Family Care Partners
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
Omega Research Consultants, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Palm Harbor Medical Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Gulfcoast Medical Research Center, Llc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Cedar-Crosse Research Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Clinical Research Advantage, Inc./Family Medicine Associates
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47725
Country
United States
Facility Name
American Health Network Of In Llc
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Columbia Medical Practice
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Drs. Rodbard And Dempsey
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Ny Clinical Trials
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
White Oak Family Physicians, Pa
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Metrolina Internal Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Medical Research Unlimited, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Lion Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Integrated Medical Group Pc / Fleetwood Medical Assoc.
City
Fleetwood
State/Province
Pennsylvania
ZIP/Postal Code
19522
Country
United States
Facility Name
Palmetto Clinical Trial Services Llc
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Dallas Diabetes & Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Covenant Clinical Research, Pa
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Independence Family Medicine
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 4W3
Country
Canada
Facility Name
Local Institution
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Local Institution
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4YI
Country
Canada
Facility Name
Local Institution
City
Collingwood
State/Province
Ontario
ZIP/Postal Code
L9Y 1W3
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 0G6
Country
Canada
Facility Name
Local Institution
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Local Institution
City
London
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Local Institution
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Local Institution
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Local Institution
City
Krnov
ZIP/Postal Code
794 01
Country
Czechia
Facility Name
Local Institution
City
Liberec
ZIP/Postal Code
460 01
Country
Czechia
Facility Name
Local Institution
City
Litomysl
ZIP/Postal Code
570 14
Country
Czechia
Facility Name
Local Institution
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Local Institution
City
Ostrava - Kuncice
ZIP/Postal Code
719 00
Country
Czechia
Facility Name
Local Institution
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Local Institution
City
Praha 1
ZIP/Postal Code
11694
Country
Czechia
Facility Name
Local Institution
City
Praha 5
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Local Institution
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
Local Institution
City
Munster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
Local Institution
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04249
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Local Institution
City
Leipzig
Country
Germany
Facility Name
Local Institution
City
Lohne
ZIP/Postal Code
32584
Country
Germany
Facility Name
Local Institution
City
Myen
ZIP/Postal Code
56727
Country
Germany
Facility Name
Local Institution
City
Papenburg
ZIP/Postal Code
D-26871
Country
Germany
Facility Name
Local Institution
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Local Institution
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Local Institution
City
Szigetvar
State/Province
Baranya
ZIP/Postal Code
7900
Country
Hungary
Facility Name
Local Institution
City
Satoraljaujhely
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3980
Country
Hungary
Facility Name
Local Institution
City
Hodmezvasarhely
State/Province
Csongrad
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Local Institution
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Local Institution
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4405
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
100036
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1183
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1212
Country
Hungary
Facility Name
Local Institution
City
Csorna
ZIP/Postal Code
9300
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Local Institution
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Local Institution
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Local Institution
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Local Institution
City
Oroshaza
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Local Institution
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Local Institution
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Local Institution
City
Szobathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Local Institution
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Local Institution
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-024
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31261
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
61-655
Country
Poland
Facility Name
Local Institution
City
Zamosc
Country
Poland
Facility Name
Fb Med Research, Psc
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Local Institution
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Local Institution
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Policlinica Dr. Luis Rodriguez
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Local Institution
City
Las Lomas
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Luis Rivera-Colon, Md
City
Las Lomas
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Ponce School Of Medicine
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Research & Cardiovascular Corp
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Caparra Internal Med Res Ctr
City
Rio Grande
ZIP/Postal Code
00745
Country
Puerto Rico
Facility Name
Local Institution
City
Rio Grande
ZIP/Postal Code
00745
Country
Puerto Rico
Facility Name
Altamira Family Medicine And Research Institute
City
San Juan
ZIP/Postal Code
00920
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00920
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00926-2832
Country
Puerto Rico
Facility Name
The Office Of Miguel Sosa-Padilla, Md
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Facility Name
Local Institution
City
Alba Iulia
ZIP/Postal Code
510053
Country
Romania
Facility Name
Local Institution
City
Bacau
ZIP/Postal Code
600114
Country
Romania
Facility Name
Local Institution
City
Bacau
ZIP/Postal Code
600164
Country
Romania
Facility Name
Local Institution
City
Baia Mare
ZIP/Postal Code
430123
Country
Romania
Facility Name
Local Institution
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Local Institution
City
Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
011234
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
010507
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
050538
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
050722
Country
Romania
Facility Name
Local Institution
City
Constanta
ZIP/Postal Code
900675
Country
Romania
Facility Name
Local Institution
City
Ploiesti
ZIP/Postal Code
100683
Country
Romania
Facility Name
Local Institution
City
Satu Mare
ZIP/Postal Code
440055
Country
Romania
Facility Name
Local Institution
City
Tg Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Local Institution
City
Mthatha
State/Province
Eastern CAPE
ZIP/Postal Code
5099
Country
South Africa
Facility Name
Local Institution
City
Port Elizabeth
State/Province
Eastern CAPE
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Local Institution
City
Welkom
State/Province
FREE State
ZIP/Postal Code
9460
Country
South Africa
Facility Name
Local Institution
City
Lyttelton
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0101
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Local Institution
City
Phoenix, Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4068
Country
South Africa
Facility Name
Local Institution
City
Brits
State/Province
North-West
ZIP/Postal Code
0250
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Local Institution
City
Worcester
State/Province
Western CAPE
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Local Institution
City
Potchefstroom
ZIP/Postal Code
2531
Country
South Africa
Facility Name
Local Institution
City
Monifieth
State/Province
AFO
ZIP/Postal Code
DD5 4LX
Country
United Kingdom
Facility Name
Local Institution
City
Carmarthen
State/Province
CAT
ZIP/Postal Code
SA31 2AF
Country
United Kingdom
Facility Name
Local Institution
City
Fife
State/Province
FIF
ZIP/Postal Code
KY14 7AW
Country
United Kingdom
Facility Name
Local Institution
City
Chippenham
State/Province
Wiltshire
ZIP/Postal Code
SN15 2SB
Country
United Kingdom
Facility Name
Local Institution
City
Chippenham
State/Province
WLT
ZIP/Postal Code
SN14 6GT
Country
United Kingdom
Facility Name
Local Institution
City
Addlestone
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Local Institution
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Local Institution
City
Cardenden Fife
ZIP/Postal Code
KY5 0JE
Country
United Kingdom
Facility Name
Local Institution
City
Dundee
ZIP/Postal Code
DD2 5NH
Country
United Kingdom
Facility Name
Local Institution
City
Dundee
ZIP/Postal Code
DD4 6RD
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Local Institution
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS clinical trial educational resource
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
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