An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)
NCT ID: NCT00095056
Last Updated: 2015-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
91 participants
INTERVENTIONAL
2004-10-31
2006-07-31
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
Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.
sitagliptin
One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily.
glipizide
One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
Placebo to glipizide
One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
Placebo
Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.
Placebo to Sitagliptin
One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily.
glipizide
One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
Interventions
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sitagliptin
One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily.
Placebo to Sitagliptin
One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily.
glipizide
One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
Placebo to glipizide
One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has renal (kidney) insufficiency (inadequate kidney function)
Exclusion Criteria
* Pregnant or breast feeding
18 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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Chan JC, Scott R, Arjona Ferreira JC, Sheng D, Gonzalez E, Davies MJ, Stein PP, Kaufman KD, Amatruda JM, Williams-Herman D. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab. 2008 Jul;10(7):545-55. doi: 10.1111/j.1463-1326.2008.00914.x. Epub 2008 Jun 1.
Other Identifiers
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2004_054
Identifier Type: -
Identifier Source: secondary_id
0431-028
Identifier Type: -
Identifier Source: org_study_id
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