Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
NCT ID: NCT00541775
Last Updated: 2015-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
273 participants
INTERVENTIONAL
2006-06-30
2007-03-31
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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Sitagliptin
sitagliptin 100 mg
Sitagliptin
Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.
Rosiglitazone
rosiglitazone 8 mg
Comparator: Rosiglitazone
Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.
Placebo
placebo
Comparator: Placebo
placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.
Interventions
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Sitagliptin
Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
Comparator: Rosiglitazone
Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
Comparator: Placebo
placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently taking metformin \>1500 mg/day for at least 10 weeks
* Male or female
Exclusion Criteria
* History of type 1 diabetes
* Patient required insulin within prior 8 weeks
* Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
* Participating in a weight loss program
18 Years
75 Years
ALL
Yes
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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Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.
Other Identifiers
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2007_623
Identifier Type: -
Identifier Source: secondary_id
0431-801
Identifier Type: -
Identifier Source: org_study_id
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