An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
NCT ID: NCT00094770
Last Updated: 2016-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1172 participants
INTERVENTIONAL
2004-09-30
2007-05-31
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 100 mg
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
sitagliptin (MK0431)
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Glipizide
Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Comparator: glipizide
Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Interventions
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sitagliptin (MK0431)
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Comparator: glipizide
Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
78 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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Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
Seck TL, Engel SS, Williams-Herman DE, Sisk CM, Golm GT, Wang H, Kaufman KD, Goldstein BJ. Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide. Diabetes Res Clin Pract. 2011 Jul;93(1):e15-7. doi: 10.1016/j.diabres.2011.03.006. Epub 2011 Apr 8.
Seck T, Nauck M, Sheng D, Sunga S, Davies MJ, Stein PP, Kaufman KD, Amatruda JM; Sitagliptin Study 024 Group. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010 Apr;64(5):562-76. doi: 10.1111/j.1742-1241.2010.02353.x.
Other Identifiers
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MK0431-024
Identifier Type: -
Identifier Source: secondary_id
2004_049
Identifier Type: -
Identifier Source: secondary_id
0431-024
Identifier Type: -
Identifier Source: org_study_id
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