MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
NCT ID: NCT00372060
Last Updated: 2017-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
134 participants
INTERVENTIONAL
2006-08-21
2008-02-05
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
MK0431 + pioglitazone
sitagliptin phosphate
Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
Comparator: pioglitazone
pioglitazone once daily for 52 weeks
2
Placebo/MK0431 + pioglitazone
Comparator: sitagliptin phosphate (MK0431)
Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
Comparator: pioglitazone
pioglitazone once daily for 52 weeks
Comparator: placebo (unspecified)
Placebo once daily for 12 weeks
Interventions
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sitagliptin phosphate
Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
Comparator: sitagliptin phosphate (MK0431)
Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
Comparator: pioglitazone
pioglitazone once daily for 52 weeks
Comparator: placebo (unspecified)
Placebo once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On Diet/Exercise Therapy And Pioglitazone As Monotherapy
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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Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC, Amatruda JM. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011 Oct 7;2(5):381-90. doi: 10.1111/j.2040-1124.2011.00120.x.
Other Identifiers
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2006_029
Identifier Type: -
Identifier Source: secondary_id
0431-055
Identifier Type: -
Identifier Source: org_study_id
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