A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
NCT ID: NCT00127192
Last Updated: 2015-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
363 participants
INTERVENTIONAL
2005-07-31
2006-03-31
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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1
Placebo QD 12-week
Comparator: placebo (unspecified)
placebo QD 12-weeks
2
25 mg QD 12-week
sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
3
50 mg QD 12-week
sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
4
100 mg QD 12-week
sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
5
200 mg QD 12-week
sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Interventions
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sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Comparator: placebo (unspecified)
placebo QD 12-weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
75 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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Iwamoto Y, Taniguchi T, Nonaka K, Okamoto T, Okuyama K, Arjona Ferreira JC, Amatruda J. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383-94. doi: 10.1507/endocrj.k09e-272. Epub 2010 Mar 24.
Other Identifiers
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MK0431-044
Identifier Type: -
Identifier Source: secondary_id
2005_037
Identifier Type: -
Identifier Source: secondary_id
0431-044
Identifier Type: -
Identifier Source: org_study_id
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