A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
NCT ID: NCT00411554
Last Updated: 2016-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
319 participants
INTERVENTIONAL
2007-01-31
2007-08-31
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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Sitagliptin 50 mg QD
sitagliptin 50 mg orally once daily (QD=once daily)
sitagliptin phosphate
sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
Voglibose 0.2 mg TID
voglibose 0.2 mg orally three times daily (TID= three times daily)
Comparator: voglibose
voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
Interventions
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sitagliptin phosphate
sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
Comparator: voglibose
voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 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, Tajima N, Kadowaki T, Nonaka K, Taniguchi T, Nishii M, Arjona Ferreira JC, Amatruda JM. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab. 2010 Jul;12(7):613-22. doi: 10.1111/j.1463-1326.2010.01197.x.
Other Identifiers
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2006_051
Identifier Type: -
Identifier Source: secondary_id
0431-054
Identifier Type: -
Identifier Source: org_study_id
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