A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
NCT ID: NCT01076075
Last Updated: 2017-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
427 participants
INTERVENTIONAL
2010-06-03
2012-01-19
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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placebo/pioglitazone
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg
Comparator: placebo to Sitagliptin
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks
Comparator: pioglitazone
Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks
Glimepiride or gliclazide
Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide
Metformin
Phase A (Weeks 0-24): stable dose, as prescribed
by investigator, of metformin; Phase B (Weeks 24-
54): stable dose, as prescribed by investigator, of
metformin
Pioglitazone rescue therapy
Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.
Sitagliptin
Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
Sitagliptin phosphate
Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks
Comparator: placebo to pioglitazone
Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks
Glimepiride or gliclazide
Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide
Metformin
Phase A (Weeks 0-24): stable dose, as prescribed
by investigator, of metformin; Phase B (Weeks 24-
54): stable dose, as prescribed by investigator, of
metformin
Pioglitazone rescue therapy
Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.
Interventions
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Sitagliptin phosphate
Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks
Comparator: placebo to pioglitazone
Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks
Comparator: placebo to Sitagliptin
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks
Comparator: pioglitazone
Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks
Glimepiride or gliclazide
Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide
Metformin
Phase A (Weeks 0-24): stable dose, as prescribed
by investigator, of metformin; Phase B (Weeks 24-
54): stable dose, as prescribed by investigator, of
metformin
Pioglitazone rescue therapy
Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemoglobin A1C of ≥7.5% and ≤10.5%
* Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
* Male, or a female who is highly unlikely to conceive
Exclusion Criteria
* Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
* On a weight loss program not in the maintenance phase or on a weight loss medication
* History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
* HIV positive
* 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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Moses RG, Round E, Shentu Y, Golm GT, O'neill EA, Gantz I, Engel SS, Kaufman KD, Goldstein BJ. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. J Diabetes. 2016 Sep;8(5):701-11. doi: 10.1111/1753-0407.12351. Epub 2016 Feb 3.
Other Identifiers
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2010_513
Identifier Type: -
Identifier Source: secondary_id
MK-0431-229
Identifier Type: OTHER
Identifier Source: secondary_id
0431-229
Identifier Type: -
Identifier Source: org_study_id
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