Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
NCT ID: NCT00509262
Last Updated: 2017-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2007-10-09
2011-03-16
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
TRIPLE
Study Groups
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Sitagliptin
Sitagliptin + Placebo for Glipizide
Sitagliptin
Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
Placebo for Glipizide
Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
Glipizide
Glipizide + Placebo for Sitagliptin
Glipizide
Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
Placebo for Sitagliptin
Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
Interventions
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Sitagliptin
Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
Glipizide
Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
Placebo for Sitagliptin
Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
Placebo for Glipizide
Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has moderate or severe renal insufficiency
Exclusion Criteria
* Is on a new weight loss program
* Has active liver disease
* Is on dialysis or is likely to need dialysis during the study
30 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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References
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Arjona Ferreira JC, Marre M, Barzilai N, Guo H, Golm GT, Sisk CM, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.
Other Identifiers
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2007_549
Identifier Type: OTHER
Identifier Source: secondary_id
0431-063
Identifier Type: -
Identifier Source: org_study_id
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