Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
423 participants
INTERVENTIONAL
2003-05-31
2004-05-31
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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Saxagliptin (2.5 mg)
Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Saxagliptin (5 mg)
Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Saxagliptin (10 mg)
Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Saxagliptin (20 mg)
Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Saxagliptin (40 mg)
Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Saxagliptin (100 mg)
Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Placebo
Placebo
Tablets, Oral, 0 mg, once daily, 6 and 12 weeks
Interventions
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Saxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Saxagliptin
Tablets, Oral, 5 mg, once daily, 12 weeks
Saxagliptin
Tablets, Oral, 10 mg, once daily, 12 weeks
Saxagliptin
Tablets, Oral, 20 mg, once daily, 12 weeks
Saxagliptin
Tablets, Oral, 40 mg, once daily, 12 weeks
Saxagliptin
Tablets, Oral, 100 mg, once daily, 6 weeks
Placebo
Tablets, Oral, 0 mg, once daily, 6 and 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Screening HbA1c ≥ 6.8% and ≤ 9.7%
* Screening fasting or random C-peptide \> 0.5 ng/mL
* \< 35 years old must be negative for anti-GAD antibodies
* Body Mass Index \< 35 kg/m2
Exclusion Criteria
* History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
* Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
* Significant cardiovascular history
21 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
References
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Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008 May;10(5):376-86. doi: 10.1111/j.1463-1326.2008.00876.x. Epub 2008 Mar 18.
Other Identifiers
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CV181-008
Identifier Type: -
Identifier Source: org_study_id
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