Phase 3
Completed N=14,671
Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
Source: ClinicalTrials.gov NCT00790205 ↗Enrolled (actual)
14,671
Serious AEs
12.6%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) — 9.6; 9.6 Percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
2,586citations · ~235 / year
Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.
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.
Linked Publications (5)
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Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.
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Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease.
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Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).
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Estimating Risk Factor Time Paths Among People with Type 2 Diabetes and QALY Gains from Risk Factor Management.
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Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) |
9.6; 9.6 | <0.001 sig |
| PRIMARY Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) |
11.4; 11.6 | <0.001 sig |
| SECONDARY Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population) |
8.4; 8.3 | <0.001 sig |
| SECONDARY Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population) |
10.2; 10.2 | <0.001 sig |
| SECONDARY Percent Incidence of All-cause Mortality (Per Protocol Population) |
4.7; 4.3 | 0.435 |
| SECONDARY Percent Incidence of All-cause Mortality (Intent to Treat Population) |
7.5; 7.3 | 0.875 |
| SECONDARY Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population) |
2.8; 2.8 | 0.858 |
| SECONDARY Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population) |
3.1; 3.1 | 0.983 |
| SECONDARY Change From Baseline in Renal Function Over Time (Per Protocol Population) |
-1.9; -0.8; -2.5; -0.9; -1.8; -0.5 | — |
| SECONDARY Change From Baseline in Renal Function Over Time (Intent to Treat Population) |
-1.8; -0.8; -2.4; -0.9; -1.8; -0.5 | — |
| SECONDARY Change From Baseline in HbA1c Over Time (Per Protocol Population) |
-0.3; 0.1; -0.3; 0.1; -0.2; 0.1 | — |
| SECONDARY Change From Baseline in HbA1c Over Time (Intent to Treat Population) |
-0.3; 0.1; -0.2; 0.1; -0.2; 0.1 | — |
| SECONDARY Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population) |
-2.2; -1.4; 1.7; 0.2; 0.8; 1.2 | — |
| SECONDARY Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population) |
-2.1; -1.4; 2.1; 0.5; 1.3; 1.2 | — |
| SECONDARY Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population) |
8.6; 11.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population) |
9.7; 13.2 | <0.001 sig |
| SECONDARY Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population) |
18.9; 24.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population) |
21.7; 27.9 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Has a history of type 1 diabetes mellitus or ketoacidosis.
- Is not able to take sitagliptin
Data sourced from ClinicalTrials.gov (NCT00790205) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.