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Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)

NCT ID: NCT00790205

Last Updated: 2021-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14671 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-10

Study Completion Date

2015-03-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sitagliptin

Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.

Placebo

Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.

Interventions

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Sitagliptin

Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.

Intervention Type DRUG

Placebo

Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.

Intervention Type DRUG

Other Intervention Names

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MK-0431 Januvia®

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Clinical Research Institute, Oxford Diabetes Trials Unit

UNKNOWN

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Argentina Australia Belgium Brazil Bulgaria Canada Chile China Colombia Czechia Estonia Finland France Germany Hong Kong Hungary India Israel Italy Latvia Lithuania Malaysia Netherlands New Zealand Norway Poland Romania Russia Singapore Slovakia South Africa South Korea Spain Sweden Taiwan Turkey (Türkiye) Ukraine United Kingdom United States

References

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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 established cardiovascular disease. Am Heart J. 2013 Dec;166(6):983-989.e7. doi: 10.1016/j.ahj.2013.09.003. Epub 2013 Oct 23.

Reference Type RESULT
PMID: 24268212 (View on PubMed)

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). Diabetes Obes Metab. 2015 Apr;17(4):395-402. doi: 10.1111/dom.12441. Epub 2015 Feb 13.

Reference Type RESULT
PMID: 25600421 (View on PubMed)

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 Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015 Jul 16;373(3):232-42. doi: 10.1056/NEJMoa1501352. Epub 2015 Jun 8.

Reference Type RESULT
PMID: 26052984 (View on PubMed)

Gao N, Dakin HA, Holman RR, Lim LL, Leal J, Clarke P. Estimating Risk Factor Time Paths Among People with Type 2 Diabetes and QALY Gains from Risk Factor Management. Pharmacoeconomics. 2024 Sep;42(9):1017-1028. doi: 10.1007/s40273-024-01398-4. Epub 2024 Jun 26.

Reference Type DERIVED
PMID: 38922488 (View on PubMed)

Bethel MA, Sourij H, Stevens SR, Hannan K, Lokhnygina Y, Adler AI, Peterson ED, Holman RR, Lopes RD. Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease. Cardiovasc Diabetol. 2023 Mar 28;22(1):72. doi: 10.1186/s12933-023-01802-x.

Reference Type DERIVED
PMID: 36978066 (View on PubMed)

Sharma A, Zheng Y, Ezekowitz JA, Westerhout CM, Udell JA, Goodman SG, Armstrong PW, Buse JB, Green JB, Josse RG, Kaufman KD, McGuire DK, Ambrosio G, Chuang LM, Lopes RD, Peterson ED, Holman RR. Cluster Analysis of Cardiovascular Phenotypes in Patients With Type 2 Diabetes and Established Atherosclerotic Cardiovascular Disease: A Potential Approach to Precision Medicine. Diabetes Care. 2022 Jan 1;45(1):204-212. doi: 10.2337/dc20-2806.

Reference Type DERIVED
PMID: 34716214 (View on PubMed)

McAlister FA, Zheng Y, Westerhout CM, Buse JB, Standl E, McGuire DK, Van de Werf F, Green JB, Armstrong PW, Holman RR; TECOS Study Group. Association between glycated haemoglobin levels and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease: a secondary analysis of the TECOS randomized clinical trial. Eur J Heart Fail. 2020 Nov;22(11):2026-2034. doi: 10.1002/ejhf.1958. Epub 2020 Jul 28.

Reference Type DERIVED
PMID: 32621557 (View on PubMed)

De Ferrari GM, Stevens SR, Ambrosio G, Leonardi S, Armstrong PW, Green JB, Wamil M, Holman RR, Peterson ED; TECOS Study Group. Low-density lipoprotein cholesterol treatment and outcomes in patients with type 2 diabetes and established cardiovascular disease: Insights from TECOS. Am Heart J. 2020 Feb;220:82-88. doi: 10.1016/j.ahj.2019.11.005. Epub 2019 Nov 13.

Reference Type DERIVED
PMID: 31790905 (View on PubMed)

Shavadia JS, Zheng Y, Green JB, Armstrong PW, Westerhout CM, McGuire DK, Cornel JH, Holman RR, Peterson ED. Associations between beta-blocker therapy and cardiovascular outcomes in patients with diabetes and established cardiovascular disease. Am Heart J. 2019 Dec;218:92-99. doi: 10.1016/j.ahj.2019.09.013. Epub 2019 Oct 20.

Reference Type DERIVED
PMID: 31715435 (View on PubMed)

Nauck MA, McGuire DK, Pieper KS, Lokhnygina Y, Strandberg TE, Riefflin A, Delibasi T, Peterson ED, White HD, Scott R, Holman RR. Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes: observations from TECOS. Cardiovasc Diabetol. 2019 Sep 3;18(1):116. doi: 10.1186/s12933-019-0921-2.

Reference Type DERIVED
PMID: 31481069 (View on PubMed)

Guimaraes PO, Peterson ED, Stevens SR, Lokhnygina Y, Green JB, McGuire DK, Holman RR, Lopes RD. Antithrombotic treatment gap among patients with atrial fibrillation and type 2 diabetes. Int J Cardiol. 2019 Aug 15;289:58-62. doi: 10.1016/j.ijcard.2019.04.085. Epub 2019 Apr 30.

Reference Type DERIVED
PMID: 31079973 (View on PubMed)

Reed SD, Li Y, Leal J, Radican L, Adler AI, Alfredsson J, Buse JB, Green JB, Kaufman KD, Riefflin A, Van de Werf F, Peterson ED, Gray AM, Holman RR; TECOS Study Group. Longitudinal medical resources and costs among type 2 diabetes patients participating in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2018 Jul;20(7):1732-1739. doi: 10.1111/dom.13292. Epub 2018 Apr 20.

Reference Type DERIVED
PMID: 29573215 (View on PubMed)

Standl E, Stevens SR, Armstrong PW, Buse JB, Chan JCN, Green JB, Lachin JM, Scheen A, Travert F, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Increased Risk of Severe Hypoglycemic Events Before and After Cardiovascular Outcomes in TECOS Suggests an At-Risk Type 2 Diabetes Frail Patient Phenotype. Diabetes Care. 2018 Mar;41(3):596-603. doi: 10.2337/dc17-1778. Epub 2018 Jan 8.

Reference Type DERIVED
PMID: 29311155 (View on PubMed)

Sharma A, Green JB, Dunning A, Lokhnygina Y, Al-Khatib SM, Lopes RD, Buse JB, Lachin JM, Van de Werf F, Armstrong PW, Kaufman KD, Standl E, Chan JCN, Distiller LA, Scott R, Peterson ED, Holman RR; TECOS Study Group. Causes of Death in a Contemporary Cohort of Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Insights From the TECOS Trial. Diabetes Care. 2017 Dec;40(12):1763-1770. doi: 10.2337/dc17-1091. Epub 2017 Oct 6.

Reference Type DERIVED
PMID: 28986504 (View on PubMed)

Pagidipati NJ, Navar AM, Pieper KS, Green JB, Bethel MA, Armstrong PW, Josse RG, McGuire DK, Lokhnygina Y, Cornel JH, Halvorsen S, Strandberg TE, Delibasi T, Holman RR, Peterson ED; TECOS Study Group. Secondary Prevention of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus: International Insights From the TECOS Trial (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). Circulation. 2017 Sep 26;136(13):1193-1203. doi: 10.1161/CIRCULATIONAHA.117.027252. Epub 2017 Jun 16.

Reference Type DERIVED
PMID: 28626088 (View on PubMed)

Bethel MA, Engel SS, Green JB, Huang Z, Josse RG, Kaufman KD, Standl E, Suryawanshi S, Van de Werf F, McGuire DK, Peterson ED, Holman RR; TECOS Study Group. Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Care. 2017 Apr;40(4):494-501. doi: 10.2337/dc16-1135. Epub 2017 Jan 5.

Reference Type DERIVED
PMID: 28057693 (View on PubMed)

Cornel JH, Bakris GL, Stevens SR, Alvarsson M, Bax WA, Chuang LM, Engel SS, Lopes RD, McGuire DK, Riefflin A, Rodbard HW, Sinay I, Tankova T, Wainstein J, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Kidney Function and Respective Cardiovascular Outcomes in Type 2 Diabetes: Outcomes From TECOS. Diabetes Care. 2016 Dec;39(12):2304-2310. doi: 10.2337/dc16-1415. Epub 2016 Oct 14.

Reference Type DERIVED
PMID: 27742728 (View on PubMed)

Buse JB, Bethel MA, Green JB, Stevens SR, Lokhnygina Y, Aschner P, Grado CR, Tankova T, Wainstein J, Josse R, Lachin JM, Engel SS, Patel K, Peterson ED, Holman RR; TECOS Study Group. Pancreatic Safety of Sitagliptin in the TECOS Study. Diabetes Care. 2017 Feb;40(2):164-170. doi: 10.2337/dc15-2780. Epub 2016 Sep 14.

Reference Type DERIVED
PMID: 27630212 (View on PubMed)

McGuire DK, Van de Werf F, Armstrong PW, Standl E, Koglin J, Green JB, Bethel MA, Cornel JH, Lopes RD, Halvorsen S, Ambrosio G, Buse JB, Josse RG, Lachin JM, Pencina MJ, Garg J, Lokhnygina Y, Holman RR, Peterson ED; Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS) Study Group. Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):126-35. doi: 10.1001/jamacardio.2016.0103.

Reference Type DERIVED
PMID: 27437883 (View on PubMed)

Other Identifiers

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2008_523

Identifier Type: OTHER

Identifier Source: secondary_id

2008-006719-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0431-082

Identifier Type: -

Identifier Source: org_study_id