Table 1 Basic characteristics of CVOTs started after 2008 FDA regulation
From: Current perspectives on cardiovascular outcome trials in diabetes
| Â | 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 inhibitor | 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 inhibitor | Liraglutide vs. placebo | CV death, MI, or stroke | 9340 | 3.8 | 08.2010–12.2015 | NCT01179048 |
SUSTAIN-6 | Completed | Semaglutide | GLP-1 inhibitor | Semaglutide 0.5 mg vs. semaglutide 1.0 mg vs. placebo | CV death, MI, or stroke | 3299 | 1.99 | 02.2013–01.2016 | NCT01720446 |
EXSCEL | Ongoing, not recruiting | Exenatide | GLP-1 inhibitor | Exenatide once weekly vs. placebo | CV death, MI, or stroke | 14,000 |  | 06.2010–04.2018 | NCT01144338 |
CAROLINA | Ongoing, not recruiting | Linagliptin | DPP-4 inhibitor | Liraglutide vs. placebo | CV death, MI, UA, or stroke | 6000 |  | 10.2010–09.2018 | NCT01243424 |
REWIND | Ongoing, not recruiting | Dulaglutide | GLP-1 inhibitor | Dulaglutide vs. placebo | CV death, MI, or stroke | 9622 |  | 07.2011–01.2016 | NCT01394952 |
ITCA650 | Ongoing, not recruiting | Exenatide in DUROS | GLP-1 inhibitor | ITCA 650 (exenatide in DUROS) vs. placebo | CV death, MI, UA, or stroke | 4000 |  | 03.2013–07.2018 | 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 |  | 07.2013–01.2018 | NCT01897532 |
DEVOTE | Ongoing, not recruiting | Insulin degludec | Basal insulins | Insulin degludec vs. insulin glargine | CV death, MI, or stroke | 7637 |  | 10.2013–09.2016 | NCT01959529 |
MK-3102 | Ongoing, not recruiting | MK-3102 | DPP-4 inhibitor | MK-3102 vs. placebo | CV death, MI, UA, or stroke | 4202 |  | 10.2012–12.2020 | NCT01703208 |
Ertugliflozin trial | Ongoing, not recruiting | Ertugliflozin | SGLT-2 inhibitor | Ertugliflozin 5 mg vs. ertugliflozin 15 mg vs. placebo | CV death, MI, or stroke | 3900 |  | 11.2013–06.2020 | NCT01986881 |
TOSCA-IT | Ongoing, not recruiting | Pioglitazone | PPAR-γ agonists | Pioglitazone vs. sulfonylurea | Death, MI, stroke or coronary revascularisation | 3371 |  | 09.2008–12.2018 | NCT00700856 |
CANVAS | Ongoing, not recruiting | Canagliflozin | SGLT-2 inhibitor | Canagliflozin 100 mg vs. canagliflozin 300 mg vs. placebo | CV death, MI, UA, or stroke | 4418 |  | 12.2009–06.2017 | NCT01032629 |