Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
NCT ID: NCT01076088
Last Updated: 2017-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
744 participants
INTERVENTIONAL
2010-11-15
2012-12-24
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 50 mg + metformin 500 mg
Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks.
Sitagliptin 50 mg
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Metformin 500 mg
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Sitagliptin 50 mg + metformin 850 mg
Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.
Sitagliptin 50 mg
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Metformin 850 mg
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Metformin 500 mg
Metformin 500 mg twice daily for 24 weeks.
Metformin 500 mg
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Metformin 850 mg
Metformin 850 mg twice daily for 24 weeks.
Metformin 850 mg
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Sitagliptin 100 mg
Sitagliptin 100 mg once daily for 24 weeks.
Sitagliptin 100 mg
Sitagliptin 100 mg once daily for 24 weeks.
Placebo
Matching placebo tablets for 24 weeks.
Placebo
Matching placebo tablets to sitagliptin or metformin for 24 weeks.
Interventions
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Sitagliptin 50 mg
Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
Metformin 500 mg
Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Sitagliptin 100 mg
Sitagliptin 100 mg once daily for 24 weeks.
Placebo
Matching placebo tablets to sitagliptin or metformin for 24 weeks.
Metformin 850 mg
Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* is male, a female who cannot have children, or a female who agrees to use birth control during the study
* is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)
Exclusion Criteria
* Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
* Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
* Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
* Patient is HIV positive
* Patient is pregnant
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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Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.
Other Identifiers
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2010_514
Identifier Type: OTHER
Identifier Source: secondary_id
0431-121
Identifier Type: -
Identifier Source: org_study_id
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