Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
NCT ID: NCT00305604
Last Updated: 2017-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2006-03-08
2008-03-12
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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1
sitagliptin
sitagliptin phosphate
Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.
2
Placebo
Comparator: Placebo
sitagliptin matching placebo for up to a 24-wk treatment period.
Interventions
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sitagliptin phosphate
Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.
Comparator: Placebo
sitagliptin matching placebo for up to a 24-wk treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit
Exclusion Criteria
* History of ketoacidosis or requires insulin use
* Alanine aminotransferase / aspartate aminotransferase \> 2.5 X ULN, triglycerides \> 600 mg/dL, creatinine clearance \< 35 mL/min
* Fasting plasma glucose consistently \> 260 mg/dL
* Poorly controlled hypertension
65 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Barzilai N, Guo H, Mahoney EM, Caporossi S, Golm GT, Langdon RB, Williams-Herman D, Kaufman KD, Amatruda JM, Goldstein BJ, Steinberg H. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011 May;27(5):1049-58. doi: 10.1185/03007995.2011.568059. Epub 2011 Mar 23.
Other Identifiers
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MK0431-047
Identifier Type: -
Identifier Source: secondary_id
2006_003
Identifier Type: -
Identifier Source: secondary_id
0431-047
Identifier Type: -
Identifier Source: org_study_id
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