Table 1 Randomised clinical trials investigating long-term cardiovascular outcomes with incretin-based therapies in people with T2D
From: The cardiovascular safety of incretin-based therapies: a review of the evidence
Title | Trial acronym | Intervention | Enrolment | Study duration | Primary outcome measure | Date initiated (month/year) | Primary completion date (month/year) |
|---|---|---|---|---|---|---|---|
GLP-1 receptor agonists | |||||||
A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects with Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease/NCT01018173 | T-EMERGE-8 | Taspoglutide 20 mg once weekly | 2118 | Event-driven timeframe, ≤2 years anticipated | Time to a CV composite endpoint (CV death, acute MI, stroke or hospitalisation for unstable angina) | 01/2010 | Trial suspended 09/2010 due to high discontinuation rates (gastrointestinal intolerability and serious hypersensitivity reactions) |
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation/NCT01179048 | LEADER | Liraglutide 1.8 mg OD | 9340 | ≤60 months | Time from randomisation to first occurrence of CV death, non-fatal MI or non-fatal stroke | 08/2010 | 01/2016 |
Exenatide Study of Cardiovascular Event Lowering Trial: A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus/NCT01144338 | EXSCEL | Exenatide 2Â mg once weekly | 9500 | 5.5Â years | Time to first confirmed CV event in a composite CV endpoint | 06/2010 | 03/2017 |
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)/NCT01147250 | ELIXA | Lixisenatide 20 μg OD | 6000 | 203 weeks | Time to first confirmed CV event | 06/2010 | 09/2014 |
Researching Cardiovascular Events With a Weekly Incretin in Diabetes/NCT01394952 | REWIND | Dulaglutide 1.5 mg once weekly | 9622 | ≤6.5 years | Time from randomisation to first occurrence of CV death, non-fatal MI or non-fatal stroke | 07/2011 | 04/2019 |
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes/ NCT01720446 | SUSTAIN 6 | Semaglutide 0.5 mg or 1.0 mg once weekly | 3260 | ≤148 weeks | Time from randomisation to first occurrence of CV death, non-fatal MI or non-fatal stroke | 02/2013 | 01/2016 |
DPP-4 inhibitors | |||||||
Sitagliptin Cardiovascular Outcome Study (0431–082 AM1)/NCT00790205 | TECOS | Sitagliptin phosphate 50 mg or 100 mg OD | 14000 | ≤5 years | Time to first confirmed CV event | 12/2008 | 12/2014 |
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications/NCT01107886 | SAVOR- TIMI 53 | Saxagliptin 2.5 mg or 5 mg OD | 16492 | ≤2.1 years | Time from randomisation to first occurrence of CV death, non-fatal MI or non-fatal stroke | 05/2010 | Completed 05/2013 |
Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes/NCT01243424 | CAROLINA | Linagliptin 5Â mg OD | 6000 | 400Â weeks | Time from randomisation to first occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalisation for unstable angina pectoris | 10/2010 | 09/2018 |
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus at High Vascular Risk/NCT01897532 | CARMELINA | Linagliptin 5Â mg OD | 8300 | 48Â months | Time to first occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalisation for unstable angina pectoris | 07/2013 | 01/2018 |
Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome/NCT00968708 | EXAMINE | Alogliptin 25Â mg OD | 5380 | 40Â months | Time from randomisation to first occurrence of CV death, non-fatal MI or non-fatal stroke | 09/2009 | Completed 06/2013 |