30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)
NCT ID: NCT01028391
Last Updated: 2017-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
317 participants
INTERVENTIONAL
2007-09-01
2009-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sitagliptin + Pioglitazone
Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.
Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets.
Metformin
Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.
Pioglitazone + Placebo
Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.
Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets.
Metformin
Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.
Interventions
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Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.
Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets.
Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.
Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets.
Metformin
Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods
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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Yoon KH, Shockey GR, Teng R, Golm GT, Thakkar PR, Meehan AG, Williams-Herman DE, Kaufman KD, Amatruda JM, Steinberg H. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011 Feb;65(2):154-64. doi: 10.1111/j.1742-1241.2010.02589.x.
Yoon KH, Steinberg H, Teng R, Golm GT, Lee M, O'Neill EA, Kaufman KD, Goldstein BJ. Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: a 54-week study. Diabetes Obes Metab. 2012 Aug;14(8):745-52. doi: 10.1111/j.1463-1326.2012.01594.x. Epub 2012 Apr 17.
Other Identifiers
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MK0431-064-10
Identifier Type: -
Identifier Source: secondary_id
2009_003
Identifier Type: -
Identifier Source: secondary_id
0431-064-10
Identifier Type: -
Identifier Source: org_study_id
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