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Table 1 Basic characteristics of CVOTs started after 2008 FDA regulation

From: Updates on cardiovascular outcome trials in diabetes

 

Study status

Drug

Drug class

Intervention

Primary outcome

N

Follow-up (years)

Start and estimated end date

Clinicaltrials.gov ID

SAVOR-TIMI53

Completed

Saxagliptin

DPP-4 inhibitor

Addition of saxagliptin vs. placebo to usual diabetes care

CV death, MI, or stroke

18,206

2.1

05.2010–05.2013

NCT01107886

EXAMINE

Completed

Alogliptin

DPP-4 inhibitor

Addition of alogliptin vs. placebo to usual diabetes care

CV death, MI, or stroke

5380

1.5

10.2009–06.2013

NCT00968708

TECOS

Completed

Sitagliptin

DPP-4 inhibitor

Sitagliptin vs. placebo

CV death, MI, UA, or stroke

14,724

3

12.2008–03.2015

NCT00790205

ELIXA

Completed

Lixisenatide

GLP-1 receptor agonist

Lixisenatide vs. placebo

CV death, MI, UA, or stroke

6076

2.1

06.2010–02.2015

NCT01147250

EMPA-REG OUTCOME

Completed

Empagliflozin

SGLT-2 inhibitor

Empagliflozin 10 mg vs. empagliflozin 25 mg vs. placebo

CV death, MI, or stroke

7000

3.1

07.2010–04.2015

NCT01131676

LEADER

Completed

Liraglutide

GLP-1 receptor agonist

Liraglutide vs. placebo

CV death, MI, or stroke

9340

3.8

08.2010–12.2015

NCT01179048

SUSTAIN-6

Completed

Semaglutide

GLP-1 receptor agonist

Semaglutide 0.5 mg vs. semaglutide 1.0 mg vs. placebo

CV death, MI, or stroke

3299

1.9

02.2013–01.2016

NCT01720446

EXSCEL

Completed

Exenatide

GLP-1 receptor agonist

Exenatide once-weekly vs. placebo

CV death, MI, or stroke

14,752

3.2

06.2010–04.2017

NCT01144338

CAROLINA

Ongoing, not recruiting

Linagliptin

DPP-4 inhibitor

Linagliptin vs. sulfonylureas vs. placebo

CV death, MI, UA, or stroke

6000

10.2010–03.2019

NCT01243424

REWIND

Ongoing, not recruiting

Dulaglutide

GLP-1 receptor agonist

Dulaglutide vs. placebo

CV death, MI, or stroke

9622

07.2011–07.2018

NCT01394952

ITCA650

Completed

Exenatide in DUROS

GLP-1 receptor agonist

ITCA 650 (exenatide in DUROS) vs. placebo

CV death, MI, UA, or stroke

4000

03.2013–03.2016

NCT01455896

DECLARE-TIMI

Ongoing, not recruiting

Dapagliflozin

SGLT-2 inhibitor

Dapagliflozin 10 mg vs. placebo

CV death, MI, or stroke

17,276

01.2013–04.2019

NCT01730534

CARMELINA

Ongoing, not recruiting

Linagliptin

DPP-4 inhibitor

Linagliptin vs. placebo

CV death, MI, UA, or stroke

8000

07.2013–12.2017

NCT01897532

DEVOTE

Completed

Insulin degludec

Basal insulins

Insulin degludec vs. insulin glargine

CV death, MI, or stroke

7637

1.9

10.2013–10.2016

NCT01959529

MK-3102

Terminated

MK-3102

DPP-4 inhibitor

MK-3102 vs. placebo

CV death, MI, UA, or stroke

4202

10.2012–03.2017

NCT01703208

VERTIS

Ongoing, not recruiting

Ertugliflozin

SGLT-2 inhibitor

Ertugliflozin 5 mg vs. ertugliflozin 15 mg vs. placebo

CV death, MI, or stroke

3900

11.2013–10.2019

NCT01986881

CANVAS program

Completed

Canagliflozin

SGLT-2 inhibitor

Canagliflozin 100 mg vs. canagliflozin 300 mg vs. placebo

CV death, MI or stroke

10,142

1.5

12.2009–02.2017

NCT01032629

Albiglutide trial

Ongoing, not recruiting

Albiglutide

GLP-1 receptor agonist

Albiglutide 30 mg vs. albiglutide 50 mg vs. placebo

CV death, MI or stroke

9400

07.2015–02.2018

NCT02465515

ACE

Completed

Acarbose

α-Glucosidase inhibitor

Acarbose vs. placebo

CV death, MI or stroke

6522

5.0

02.2009–04.2017

NCT00829660