Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)

Type 2 Diabetes Mellitus Clinical Trial

— TECOS  

Official title:

TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790205
• Other study ID #: 0431-082
• Secondary ID: 2008_5232008-006
• Status: Completed
• Phase: Phase 3
• Start date: December 10, 2008
• Est. completion date: March 30, 2015

Study information

• Verified date: October 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14671
• Est. completion date: March 30, 2015
• Est. primary completion date: March 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.
• Placebo
Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Duke Clinical Research Institute, Oxford Diabetes Trials Unit

References & Publications (3)

Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM, Holman RR; TECOS Executive Committee. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). — View Citation

Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on C — View Citation

Green JB, Bethel MA, Paul SK, Ring A, Kaufman KD, Shapiro DR, Califf RM, Holman RR. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and esta — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)	Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.	Up to 5 years
Primary	Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)	Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.	Up to 5 years
Secondary	Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)	CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.	Up to 5 years
Secondary	Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)	CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.	Up to 5 years
Secondary	Percent Incidence of All-cause Mortality (Per Protocol Population)	Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.	Up to 5 years
Secondary	Percent Incidence of All-cause Mortality (Intent to Treat Population)	Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.	Up to 5 years
Secondary	Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)	Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.	Up to 5 years
Secondary	Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)	Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.	Up to 5 years
Secondary	Change From Baseline in Renal Function Over Time (Per Protocol Population)	Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.	Baseline and up to 5 years
Secondary	Change From Baseline in Renal Function Over Time (Intent to Treat Population)	Change in renal function based on eGFR using the MDRD method.	Baseline and up to 5 years
Secondary	Change From Baseline in HbA1c Over Time (Per Protocol Population)	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.	Baseline and up to 4 years
Secondary	Change From Baseline in HbA1c Over Time (Intent to Treat Population)	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.	Baseline and up to 4 years
Secondary	Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)	Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.	Baseline and up to 5 years
Secondary	Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)	Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.	Baseline and up to 5 years
Secondary	Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)	Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.	Up to 5 years
Secondary	Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)	Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.	Up to 5 years
Secondary	Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)	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.)	Up to 5 years
Secondary	Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)	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.)	Up to 5 years