Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
NCT ID: NCT00758069
Last Updated: 2017-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2005-07-03
2006-02-13
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
Comparator: Placebo
Placebo tablet, QD, taken orally for 4 weeks
2
Sitagliptin 100 mg
sitagliptin phosphate
100 mg once daily (QD), taken orally for 4 weeks
3
Sitagliptin 50 mg
Comparator: Sitagliptin
50 mg twice daily (BID), taken orally for 4 weeks
Interventions
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sitagliptin phosphate
100 mg once daily (QD), taken orally for 4 weeks
Comparator: Placebo
Placebo tablet, QD, taken orally for 4 weeks
Comparator: Sitagliptin
50 mg twice daily (BID), taken orally for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
69 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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Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.
Study Documents
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Document Type: CSR Synopsis
View DocumentOther Identifiers
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MK0431-045
Identifier Type: -
Identifier Source: secondary_id
2008_026
Identifier Type: -
Identifier Source: secondary_id
0431-045
Identifier Type: -
Identifier Source: org_study_id
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