6/28/23, 10:58 PM LEADER Pathway Feedback Search Clinical Topics Home Studies LEADER LEADER Disease Diabetes mellitus type 2 Trial question What is the effect of liraglutide in patients with T2DM and high cardiovascular risk? Study design Multi-center Double blinded RCT Population Characteristics of study participants 36.0% female N = 9340 64.0% male 9340 patients (3337 female, 6003 male) Inclusion criteria: patients with T2DM who had a glycated Hgb level of 7.0% and high cardiovascular risk Key exclusion criteria: T1DM, calcitonin 50 ng/L, chronic HF, current continuous RRT, end-stage renal disease, history of solid organ transplant or awaiting solid organ transplant, malignant neoplasm, personal history of non-familial medullary thyroid carcinoma Interventions N=4668 liraglutide (1.8 mg or maximum tolerated dose once daily as a subcutaneous injection in addition to standard care) N=4672 placebo (matching placebo once daily as a subcutaneous injection in addition to standard care) https://web.pathway.md/studies/recToD4bL8Mx5VaVo 1/2 6/28/23, 10:58 PM LEADER Pathway Primary outcome Death due to cardiovascular causes 6.0 % 6 4.7 4.5 % 3.0 % Significant decrease 1.5 % NNT = 77 0.0 % Liraglutide Placebo Significant decrease in death due to cardiovascular causes (4.7% vs. 6%; HR 0.78, 95% CI 0.66 to 0.93) Safety outcomes No significant differences in adverse events (62.3% vs. 60.8%, p=0.12) and serious adverse events (49.7% vs. 50.4%, p=0.51). Significant differences in adverse event leading to discontinuation of trial regimen (9.5% vs. 7.3%, p < 0.001) and acute gallstone disease (3.1% vs. 1.9%, p < 0.001). Conclusion In patients with T2DM who had a glycated Hgb level of 7.0% and high cardiovascular risk, liraglutide was noninferior to placebo with respect to death due to cardiovascular causes. Reference Marso SP, Daniels GH, Brown-Frandsen K et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. Open reference URL https://web.pathway.md/studies/recToD4bL8Mx5VaVo 2/2