Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
NCT ID: NCT00541229
Last Updated: 2017-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2007-08-24
2008-07-01
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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1
sitagliptin 100 mg
sitagliptin phosphate
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
2
sitagliptin 200 mg
sitagliptin phosphate
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
3
Placebo
Comparator: Placebo
sitagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
Interventions
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sitagliptin phosphate
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
sitagliptin phosphate
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
Comparator: Placebo
sitagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is between the ages of 30-65 years
* Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin \[A1C\] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).
Exclusion Criteria
* Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
* Patient has taken insulin within the past 3 months
30 Years
65 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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Alba M, Sheng D, Guan Y, Williams-Herman D, Larson P, Sachs JR, Thornberry N, Herman G, Kaufman KD, Goldstein BJ. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009 Oct;25(10):2507-14. doi: 10.1185/03007990903209514.
Other Identifiers
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2007_533
Identifier Type: -
Identifier Source: secondary_id
0431-077
Identifier Type: -
Identifier Source: org_study_id
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