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 |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Metformin XR Drug: Metformin IR Drug: Placebo matching with Metformin XR Drug: Placebo matching with Metformin IR |
Phase | Phase 4 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT01864174 |
First Received | May 24, 2013 |
Last Updated | September 24, 2013 |
Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 24, 2013 |
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Last Updated Date | September 24, 2013 |
Start Date | June 2013 |
Estimated Primary Completion Date | November 2014 |
Current Primary Outcome Measures | Mean 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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes |
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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 |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 524 |
Estimated Completion Date | November 2014 |
Estimated Primary Completion Date | November 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) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com |
Location Countries | United States, Canada, Czech Republic, Puerto Rico |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01864174 |
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Other Study ID Numbers | CV181-206 |
Has Data Monitoring Committee | Yes |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | September 2013 |
Locations[ + expand ][ + ]
Central Alabama Research | Birmingham, Alabama, United States, 35209 Contact: Barry Mclean, Site 0130 | 205-949-1907Recruiting |
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Terence T. Hart, MD | Muscle Shoals, Alabama, United States, 35662 Contact: Terence Hart, Site 0127Recruiting |
Clini Res Advantage Desert Clin Res, LLC | Mesa, Arizona, United States, 85213 Contact: Gerald Shockey, Site 0136Recruiting |
Clinical Res Advantage Central | Phoenix, Arizona, United States, 85020 Contact: Ernie Riffer, Site 0135Recruiting |
San Diego Coastal Endocronology Grp | Chula Vista, California, United States, 91911 Contact: Georges Argoud, Stie 0131Recruiting |
Marin Endocrine Care And Research, Inc. | Greenbrae, California, United States, 94904 Contact: Linda M Gaudiani, Site 1001 | 415-461-1780Recruiting |
National Research Institute | Los Angeles, California, United States, 90057 Contact: Andrew J Lewin, Site 0140 | 213-483-1800Recruiting |
Diabetes Medical Center Of California | Northridge, California, United States, 91325 Contact: Gholamreza Bonabi, Site 1003 | 818-368-4212Recruiting |
Valley Clinical Trials | Northridge, California, United States, 91325 Contact: Christopher G Chow, Site 0129 | 818-341-4401Recruiting |
Clinical Research Advantage, Inc/CO Springs Health Partners, Briar | Colorado Springs, Colorado, United States, 80920 Contact: Caryn Baldauf, Site 0134Recruiting |
Clinical Research Advantage | Colorado Springs, Colorado, United States, 80906 Contact: Kari T Uusinarkaus, Site 0137 | 812-477-2760Recruiting |
Southeast Clinical Research, Llc | Jacksonville, Florida, United States, 32216 Contact: Kim Barbel-Johnson, site 0133Recruiting |
Omega Research Consultants, LLC | Orlando, Florida, United States, 32804 Contact: Kwabena Ayesu, Site 1011 | 407-271-8030Recruiting |
Palm Harbor Medical Associates | Palm Harbor, Florida, United States, 34684 Contact: Aron Schlau, Site 1009 | 727-785-4540Recruiting |
Cedar-Crosse Research Ctr | Chicago, Illinois, United States, 60607 Contact: Danny Sugimoto, Site 1010 | 312-431-6765Recruiting |
Clinical Research Advantage, Inc./Family Medicine Associates | Evansville, Indiana, United States, 47725 Contact: Anthony Inzerello, Site 1012 | 812-205-2904Recruiting |
Columbia Medical Practice | Columbia, Maryland, United States, 21045 Contact: William Saway, Site 1017 | 410-997-5204Recruiting |
Centennial Medical Group | Elkridge, Maryland, United States, 21075 Contact: Steven Geller, Site 1021Recruiting |
White Oak Family Physicians, PA | Asheboro, North Carolina, United States, 27203 Contact: Robert Scott, Site 1013Recruiting |
Metrolina Internal Medicine | Charlotte, North Carolina, United States, 28204 Contact: Karlton Pettis, Site 1015 | 704-374-0030Recruiting |
Medical Research Unlimited, Inc. | Cincinnati, Ohio, United States, 45242 Contact: Ginger Kubala, Site 1014Recruiting |
Palmetto Clinical Trial Services Llc | Fountain Inn, South Carolina, United States, 29644 Contact: Louis Stephens, Site 0109 | 864-962-0431Recruiting |
Clinical Research Authority, Llc | Murrells Inlet, South Carolina, United States, 29576 Contact: John Y Karl, Site 0110 | 843-651-4111Recruiting |
Holston Medical Group | Bristol, Tennessee, United States, 37620 Contact: Rick J Whiles, Site 1022 | 423-990-2497Recruiting |
Dallas Diabetes & Endocrine Center | Dallas, Texas, United States, 75230 Contact: Julio Rosenstock, Site 0124 | 972-661-7799Recruiting |
Independence Family Medicine | Virginia Beach, Virginia, United States, 23455 Contact: Michael Moro, Site 0108Recruiting |
Local Instituion | Winnipeg, Manitoba, Canada, R2V 4W3 Contact: Site 3010Recruiting |
Local Institution | Brampton, Ontario, Canada, L6T 0G1 Contact: Site 3001Recruiting |
Local Institution | Toronto, Ontario, Canada, M9W 4L6 Contact: Site 3007Recruiting |
Local Institution | Québec, Quebec, Canada, G1N 4V3 Contact: site 3003Recruiting |
Local Institution | St Romuald, Quebec, Canada, G6W 5M6 Contact: Site 3002Recruiting |
Local Institution | Ceske Budejovice, Czech Republic, 370 01 Contact: Site 0107Recruiting |
Local Institution | Caguas, Puerto Rico, 00725 Contact: Site 2002Recruiting |
Local Institution | Ponce, Puerto Rico, 00717 Contact: Site 2006Recruiting |
Ponce School Of Medicine | Ponce, Puerto Rico, 00716 Contact: Elizabeth A Barranco Santana, Site 2001 | 787-840-2505Recruiting |
Local Institution | Rio Grande, Puerto Rico, 00745 Contact: Site 0111Recruiting |
The Office Of Miguel Sosa-Padilla, Md | San Juan, Puerto Rico, 00926-2832 Contact: Miguel Sosa-Padilla, Site 2005 | 787-764-8281Recruiting |