Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
NCT ID: NCT00885378
Last Updated: 2015-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
166 participants
INTERVENTIONAL
2009-05-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Saxagliptin plus metformin IR
Saxagliptin plus metformin IR
Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
Placebo plus metformin IR
Placebo plus metformin IR
Tablets, Oral, Placebo, Twice daily, 12 weeks
Interventions
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Saxagliptin plus metformin IR
Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
Placebo plus metformin IR
Tablets, Oral, Placebo, Twice daily, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-78 years of age
* Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
* A1C: 7-10%
* C-peptide: ≥ 0.8 ng/mL
* Body mass index (BMI): ≤45 kg/m\^2
Exclusion Criteria
* Women who are pregnant or breastfeeding
* Fasting plasma glucose (FPG) \>270 mg/dL
* Significant cardiovascular history
* Symptoms of poorly controlled diabetes
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Insulin therapy within one year of screening
* Cardiovascular even within the prior 6 months
* New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction \<=40%
* Significant history of renal or hepatic disease
* History of a psychiatric disorder, alcohol or drug abuse within the previous year
* Treatment with potent CYP3A4 inhibitors or inducers
* Immunocompromised participants
* Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
18 Years
78 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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John Muir Physician Network Clinical Research Center
Concord, California, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Torrance Clinical Research
Lomita, California, United States
Ritchken & First M.D.'S
San Diego, California, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States
Family Care Associates Of Nw Florida
Chipley, Florida, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, United States
Nextphase Clinical Trials, Inc.
Miami, Florida, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States
Louisiana Heart Center Research
Slidell, Louisiana, United States
Jackson Clinic
Rolling Fork, Mississippi, United States
Community Health Care Of Manchester
Akron, Ohio, United States
Midwest Regional Research, Inc.
Bellbrook, Ohio, United States
Wells Institute For Health Awareness
Kettering, Ohio, United States
Newark Physician Associates
Newark, Ohio, United States
Integris Family Care South
Oklahoma City, Oklahoma, United States
Integris Family Care Yukon
Yukon, Oklahoma, United States
Williamette Valley Clinical Studies
Eugene, Oregon, United States
Integrated Medical Group Pc/Fleetwood Clinical Research
Fleetwood, Pennsylvania, United States
Southeastern Research Associates, Inc
Taylors, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Village Family Practice
Houston, Texas, United States
Southwest Clinical Research Centers, Llc
Pearland, Texas, United States
Jolene K. Berg, Md., Dgd Research, Inc.
San Antonio, Texas, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Local Institution
Ludwigshafen, , Germany
Local Institution
Magdeberg, , Germany
Local Institution
Pirna, , Germany
Local Institution
Saarbrücken, , Germany
Local Institution
Saarlouis, , Germany
Local Institution
Tann, , Germany
Local Institution
Wüstensachsen, , Germany
Local Institution
Balatonfüred, Hungary, Hungary
Local Institution
Budapest, , Hungary
Local Institution
Eger, , Hungary
Local Institution
Szigetvár, , Hungary
Local Institution
Zalaegerszeg, , Hungary
Local Institution
Ponce, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
Local Institution
San Juan, , Puerto Rico
Countries
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References
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White JL, Buchanan P, Li J, Frederich R. A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy. BMC Endocr Disord. 2014 Feb 24;14:17. doi: 10.1186/1472-6823-14-17.
Related Links
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Investigator Inquiry form
Other Identifiers
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EUDRACT #: 2009-010224-25
Identifier Type: -
Identifier Source: secondary_id
CV181-080
Identifier Type: -
Identifier Source: org_study_id
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