Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
NCT ID: NCT00106704
Last Updated: 2015-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
441 participants
INTERVENTIONAL
2005-03-31
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sitagliptin
Sitagliptin 10 mg tablet daily for 54 weeks
Comparator: Sitagliptin
sitagliptin 10 mg tablet, once daily for 54 weeks
Placebo/ Pioglitazone
Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
Comparator: Placebo
Placebo oral tablet once daily for 24 weeks
Comparator: Pioglitazone
Pioglitazone 30 mg tablet once daily for 30 weeks
Interventions
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Comparator: Sitagliptin
sitagliptin 10 mg tablet, once daily for 54 weeks
Comparator: Placebo
Placebo oral tablet once daily for 24 weeks
Comparator: Pioglitazone
Pioglitazone 30 mg tablet once daily for 30 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 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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Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26.
Other Identifiers
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2005_009
Identifier Type: -
Identifier Source: secondary_id
0431-035
Identifier Type: -
Identifier Source: org_study_id
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