Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
NCT ID: NCT00683657
Last Updated: 2015-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
93 participants
INTERVENTIONAL
2008-07-31
2009-02-28
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
DOUBLE
Study Groups
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Saxagliptin 5 mg + Metformin
Saxagliptin
Tablets, Oral, 5mg, once daily, 4 weeks
Placebo + Metformin
Placebo
Tablets, Oral, 0 mg, once daily, 4 weeks
Interventions
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Saxagliptin
Tablets, Oral, 5mg, once daily, 4 weeks
Placebo
Tablets, Oral, 0 mg, once daily, 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
* Glycosylated hemoglobin (A1C) ≥7% and ≤10%
* Body mass index (BMI) ≤40 kg/m2
Exclusion Criteria
* Women who are pregnant or breastfeeding
* Significant cardiovascular history
* Active liver disease
* Renal impairment
18 Years
77 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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Dedicated Phase I, Inc.
Phoenix, Arizona, United States
Amcr Institute, Inc
Escondido, California, United States
Irvine Center For Clinical Research, Inc.
Irvine, California, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, United States
Advantage Clinical Research
Santa Ana, California, United States
Orange County Research Center
Tustin, California, United States
River Birch Research Alliance, Llc
Blue Ridge, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Clinilabs, Inc.
New York, New York, United States
Covance Cru, Inc.
Portland, Oregon, United States
Dgd Research, Inc.
San Antonio, Texas, United States
Avastra Clinical Trials
Midvale, Utah, United States
Local Institution
Martínez, Buenos Aires, Argentina
Local Institution
Holon, , Israel
Local Institution
Jerusalem, , Israel
Local Institution
Kfar Saba, , Israel
Local Institution
Ẕerifin, , Israel
Local Institution
Milan, , Italy
Local Institution
Aguascalientes, Aguascalientes, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Cebu City, , Philippines
Local Institution
Marikina City, , Philippines
Local Institution
Ponce, Puerto Rico, Puerto Rico
Local Institution
Lund, Sweden, Sweden
Local Institution
Gothenburg, , Sweden
Local Institution
Huddinge, , Sweden
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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Eudract-2008-000976-26
Identifier Type: -
Identifier Source: secondary_id
CV181-066
Identifier Type: -
Identifier Source: org_study_id
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