Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
NCT ID: NCT00511108
Last Updated: 2017-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
211 participants
INTERVENTIONAL
2007-07-11
2009-02-24
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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1
Arm 1: drug
Comparator: sitagliptin phosphate
sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
Comparator: placebo to pioglitazone
pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
2
Arm 2: active comparator
Comparator: pioglitazone
pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Comparator: placebo to sitagliptin
sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
3
Arm 3: drug + active comparator
Comparator: sitagliptin phosphate
sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
Comparator: pioglitazone
pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
4
Arm 4: placebo comparator
Comparator: placebo to pioglitazone
pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Comparator: placebo to sitagliptin
sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Interventions
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Comparator: sitagliptin phosphate
sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
Comparator: pioglitazone
pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Comparator: placebo to pioglitazone
pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Comparator: placebo to sitagliptin
sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
Eligibility Criteria
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Inclusion Criteria
* Male
* Female that is highly unlikely to become pregnant
* Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)
Exclusion Criteria
* Patient has required insulin therapy within the past 12 weeks
* Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones \[TZDs\]) within the prior 12 weeks of the screening visit.
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, Ahren B, Inzucchi SE, Guan Y, Mallick M, Xu L, O'Neill EA, Williams-Herman DE, Kaufman KD, Goldstein BJ. Sitagliptin and pioglitazone provide complementary effects on postprandial glucose and pancreatic islet cell function. Diabetes Obes Metab. 2013 Dec;15(12):1101-10. doi: 10.1111/dom.12145. Epub 2013 Jul 19.
Other Identifiers
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MK0431-061
Identifier Type: -
Identifier Source: secondary_id
2007_530
Identifier Type: -
Identifier Source: secondary_id
0431-061
Identifier Type: -
Identifier Source: org_study_id
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