A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
NCT ID: NCT00374907
Last Updated: 2015-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
156 participants
INTERVENTIONAL
2006-09-30
2009-12-31
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
DOUBLE
Study Groups
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Saxagliptin (A)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
Saxagliptin
Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
Placebo (ST) / Metformin (LT) (B)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
Placebo
Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
Metformin (blinded)
Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
Metformin (open-label)
Tablets, Oral, 500-1500 mg, as needed (starting in LT)
Interventions
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Saxagliptin
Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
Placebo
Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
Metformin (blinded)
Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
Metformin (open-label)
Tablets, Oral, 500-1500 mg, as needed (starting in LT)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Drug naive
* Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
* Fasting C-peptide ≥1.0 ng/mL
* Body mass index ≤40 kg/m²
Exclusion Criteria
* Elevated serum creatinine
18 Years
70 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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Va San Diego Healthcare System
San Diego, California, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Diabetes & Glandular Disease Research Assoc,, Inc.
San Antonio, Texas, United States
Countries
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Other Identifiers
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CV181-041
Identifier Type: -
Identifier Source: org_study_id
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