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

Overview[ - collapse ][ - ]

Purpose The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy
ConditionType 2 Diabetes Mellitus
InterventionDrug: Metformin XR
Drug: Metformin IR
Drug: Placebo matching with Metformin XR
Drug: Placebo matching with Metformin IR
PhasePhase 4
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT01864174
First ReceivedMay 24, 2013
Last UpdatedSeptember 24, 2013
Last verifiedSeptember 2013

Tracking Information[ + expand ][ + ]

First Received DateMay 24, 2013
Last Updated DateSeptember 24, 2013
Start DateJune 2013
Estimated Primary Completion DateNovember 2014
Current Primary Outcome MeasuresMean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24 [Time Frame: Up to Week 24 (Double-Blind treatment period)] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Mean change in fasting plasma glucose (FPG) from baseline to Week 24 [Time Frame: Up to Week 24 (Double-Blind treatment period)] [Designated as safety issue: No]
  • Mean change in Mean Daily Glucose (MDG) from baseline to Week 24 [Time Frame: Up to Week 24 (Double-Blind treatment period)] [Designated as safety issue: No]
  • Percent of subjects with HbA1c <7% [Time Frame: Week 24] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitlePhase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Official TitleA 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
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Metformin XR
Other Names:
Glucophage XRDrug: Metformin IR
Other Names:
GlucophageDrug: Placebo matching with Metformin XR
Drug: Placebo matching with Metformin IR
Study Arm (s)
  • 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
  • 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

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment524
Estimated Completion DateNovember 2014
Estimated Primary Completion DateNovember 2014
Eligibility Criteria
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 ≥7.2% 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)
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: For participation information at a USA site use a phone number below. For Site information outside USA please email:
Clinical.Trials@bms.com
Location CountriesUnited States, Canada, Czech Republic, Puerto Rico

Administrative Information[ + expand ][ + ]

NCT Number NCT01864174
Other Study ID NumbersCV181-206
Has Data Monitoring CommitteeYes
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateSeptember 2013

Locations[ + expand ][ + ]

Central Alabama Research
Birmingham, Alabama, United States, 35209
Contact: Barry Mclean, Site 0130 | 205-949-1907
Recruiting
Terence T. Hart, MD
Muscle Shoals, Alabama, United States, 35662
Contact: Terence Hart, Site 0127
Recruiting
Clini Res Advantage Desert Clin Res, LLC
Mesa, Arizona, United States, 85213
Contact: Gerald Shockey, Site 0136
Recruiting
Clinical Res Advantage Central
Phoenix, Arizona, United States, 85020
Contact: Ernie Riffer, Site 0135
Recruiting
San Diego Coastal Endocronology Grp
Chula Vista, California, United States, 91911
Contact: Georges Argoud, Stie 0131
Recruiting
Marin Endocrine Care And Research, Inc.
Greenbrae, California, United States, 94904
Contact: Linda M Gaudiani, Site 1001 | 415-461-1780
Recruiting
National Research Institute
Los Angeles, California, United States, 90057
Contact: Andrew J Lewin, Site 0140 | 213-483-1800
Recruiting
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Contact: Gholamreza Bonabi, Site 1003 | 818-368-4212
Recruiting
Valley Clinical Trials
Northridge, California, United States, 91325
Contact: Christopher G Chow, Site 0129 | 818-341-4401
Recruiting
Clinical Research Advantage, Inc/CO Springs Health Partners, Briar
Colorado Springs, Colorado, United States, 80920
Contact: Caryn Baldauf, Site 0134
Recruiting
Clinical Research Advantage
Colorado Springs, Colorado, United States, 80906
Contact: Kari T Uusinarkaus, Site 0137 | 812-477-2760
Recruiting
Southeast Clinical Research, Llc
Jacksonville, Florida, United States, 32216
Contact: Kim Barbel-Johnson, site 0133
Recruiting
Omega Research Consultants, LLC
Orlando, Florida, United States, 32804
Contact: Kwabena Ayesu, Site 1011 | 407-271-8030
Recruiting
Palm Harbor Medical Associates
Palm Harbor, Florida, United States, 34684
Contact: Aron Schlau, Site 1009 | 727-785-4540
Recruiting
Cedar-Crosse Research Ctr
Chicago, Illinois, United States, 60607
Contact: Danny Sugimoto, Site 1010 | 312-431-6765
Recruiting
Clinical Research Advantage, Inc./Family Medicine Associates
Evansville, Indiana, United States, 47725
Contact: Anthony Inzerello, Site 1012 | 812-205-2904
Recruiting
Columbia Medical Practice
Columbia, Maryland, United States, 21045
Contact: William Saway, Site 1017 | 410-997-5204
Recruiting
Centennial Medical Group
Elkridge, Maryland, United States, 21075
Contact: Steven Geller, Site 1021
Recruiting
White Oak Family Physicians, PA
Asheboro, North Carolina, United States, 27203
Contact: Robert Scott, Site 1013
Recruiting
Metrolina Internal Medicine
Charlotte, North Carolina, United States, 28204
Contact: Karlton Pettis, Site 1015 | 704-374-0030
Recruiting
Medical Research Unlimited, Inc.
Cincinnati, Ohio, United States, 45242
Contact: Ginger Kubala, Site 1014
Recruiting
Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina, United States, 29644
Contact: Louis Stephens, Site 0109 | 864-962-0431
Recruiting
Clinical Research Authority, Llc
Murrells Inlet, South Carolina, United States, 29576
Contact: John Y Karl, Site 0110 | 843-651-4111
Recruiting
Holston Medical Group
Bristol, Tennessee, United States, 37620
Contact: Rick J Whiles, Site 1022 | 423-990-2497
Recruiting
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
Contact: Julio Rosenstock, Site 0124 | 972-661-7799
Recruiting
Independence Family Medicine
Virginia Beach, Virginia, United States, 23455
Contact: Michael Moro, Site 0108
Recruiting
Local Instituion
Winnipeg, Manitoba, Canada, R2V 4W3
Contact: Site 3010
Recruiting
Local Institution
Brampton, Ontario, Canada, L6T 0G1
Contact: Site 3001
Recruiting
Local Institution
Toronto, Ontario, Canada, M9W 4L6
Contact: Site 3007
Recruiting
Local Institution
Québec, Quebec, Canada, G1N 4V3
Contact: site 3003
Recruiting
Local Institution
St Romuald, Quebec, Canada, G6W 5M6
Contact: Site 3002
Recruiting
Local Institution
Ceske Budejovice, Czech Republic, 370 01
Contact: Site 0107
Recruiting
Local Institution
Caguas, Puerto Rico, 00725
Contact: Site 2002
Recruiting
Local Institution
Ponce, Puerto Rico, 00717
Contact: Site 2006
Recruiting
Ponce School Of Medicine
Ponce, Puerto Rico, 00716
Contact: Elizabeth A Barranco Santana, Site 2001 | 787-840-2505
Recruiting
Local Institution
Rio Grande, Puerto Rico, 00745
Contact: Site 0111
Recruiting
The Office Of Miguel Sosa-Padilla, Md
San Juan, Puerto Rico, 00926-2832
Contact: Miguel Sosa-Padilla, Site 2005 | 787-764-8281
Recruiting