An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
NCT ID: NCT00960076
Last Updated: 2011-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
282 participants
INTERVENTIONAL
2009-08-31
2010-10-31
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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1
Saxagliptin
Saxagliptin
5mg oral tablet once daily
Metformin XR
750mg, 2 tablets once daily
2
Metformin Extended Release
Metformin XR
500mg oral tablet once daily
Metformin XR
750mg, 2 tablets once daily
Interventions
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Saxagliptin
5mg oral tablet once daily
Metformin XR
500mg oral tablet once daily
Metformin XR
750mg, 2 tablets once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A1c: 7.5-11% (at screening)
* BMI less than or equal to 45 kg/m2
Exclusion Criteria
* Active liver disease, renal impairment
18 Years
78 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Boaz Hirschberg, MD
Role: STUDY_DIRECTOR
AstraZeneca
Vivian Fonseca, MD
Role: PRINCIPAL_INVESTIGATOR
Tulane University
Locations
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Research Site
Jonesboro, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Fountain Valley, California, United States
Research Site
Los Angeles, California, United States
Research Site
Pasadena, California, United States
Research Site
Sacramento, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Wellington, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
St Louis, Missouri, United States
Research Site
Salisbury, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Simpsonville, South Carolina, United States
Research Site
Bristol, Tennessee, United States
Research Site
Alexandria, Virginia, United States
Research Site
Burke, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Barranquilla, Atlántico, Colombia
Research Site
Barranquilla, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Curridabat, Provincia de San José, Costa Rica
Research Site
Los Yoses, Provincia de San José, Costa Rica
Research Site
Heredia, , Costa Rica
Research Site
México, D.f., Mexico
Research Site
Durango, Durango, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Cuernavaca, Morelos, Mexico
Research Site
Querétaro City, Querétaro, Mexico
Research Site
Lima, , Peru
Countries
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References
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Fonseca V, Zhu T, Karyekar C, Hirshberg B. Adding saxagliptin to extended-release metformin vs. uptitrating metformin dosage. Diabetes Obes Metab. 2012 Apr;14(4):365-71. doi: 10.1111/j.1463-1326.2011.01553.x. Epub 2012 Jan 18.
Other Identifiers
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D1680L00005
Identifier Type: -
Identifier Source: org_study_id