Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
- Registration Number
- NCT00790205
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.
Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14671
- Has T2DM
- Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
- Has pre-existing cardiovascular disease
- Has a history of type 1 diabetes mellitus or ketoacidosis.
- Is not able to take sitagliptin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years. Sitagliptin Sitagliptin Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
- Primary Outcome Measures
Name Time Method Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) Up to 5 years Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.
Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) Up to 5 years Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population) Up to 5 years CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.
Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population) Up to 5 years CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.
Percent Incidence of All-cause Mortality (Intent to Treat Population) Up to 5 years Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.
Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population) Up to 5 years Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.
Change From Baseline in Renal Function Over Time (Per Protocol Population) Baseline and up to 5 years Change in renal function based on estimated glomerular filtration rate \[eGFR\] using the Modification of Diet in Renal Disease \[MDRD\] method.
Change From Baseline in HbA1c Over Time (Per Protocol Population) Baseline and up to 4 years HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.
Percent Incidence of All-cause Mortality (Per Protocol Population) Up to 5 years Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.
Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population) Up to 5 years Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.
Change From Baseline in Renal Function Over Time (Intent to Treat Population) Baseline and up to 5 years Change in renal function based on eGFR using the MDRD method.
Change From Baseline in HbA1c Over Time (Intent to Treat Population) Baseline and up to 4 years HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.
Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population) Baseline and up to 5 years Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.
Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population) Baseline and up to 5 years Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.
Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population) Up to 5 years Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.
Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population) Up to 5 years Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.
Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population) Up to 5 years In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent \[AHA\] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)
Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population) Up to 5 years In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)