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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 2 mg once weekly 9500 5.5 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 5 mg OD 6000 400 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 5 mg OD 8300 48 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 25 mg OD 5380 40 months Time from randomisation to first occurrence of CV death, non-fatal MI or non-fatal stroke 09/2009 Completed 06/2013
  1. Abbreviations: CV cardiovascular, DPP-4 inhibitors, dipeptidyl peptidase-4 inhibitors, GLP-1 glucagon-like peptide-1, MI myocardial infarction, OD once daily.
  2. All are phase 3 clinical studies, except for SAVOR- TIMI 53 and CARMELINA, phase 4 trials. All are placebo-controlled trials, except for CAROLINA (NCT01243424), in which linagliptin 5 mg OD is compared with glimepiride 1–4 mg OD. All studies are double-blinded. Sources: http://www.clinicaltrials.gov; [1424].