A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
NCT ID: NCT00701090
Last Updated: 2017-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1035 participants
INTERVENTIONAL
2008-05-31
2009-10-31
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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1
sitagliptin
sitagliptin
Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
open-label metformin
open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
2
glimepiride
Comparator: glimepiride
glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
open-label metformin
open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
Interventions
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sitagliptin
Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
Comparator: glimepiride
glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
open-label metformin
open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes
* On a stable dose of metformin of at least 1500 mg per day
Exclusion Criteria
* Pregnant
* HIV positive
* On a weight loss program or medication
* Has a history of blood disorder, certain cancers, heart, liver or kidney disease
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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Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011 Feb;13(2):160-8. doi: 10.1111/j.1463-1326.2010.01334.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.
Other Identifiers
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2008_503
Identifier Type: -
Identifier Source: secondary_id
0431-803
Identifier Type: -
Identifier Source: org_study_id
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