Key inclusion criteria:
T2D, A1C ≥7.0%
Cardiovascular outcomes trial for Victoza®

Consider a once-weekly GLP‑1 RA therapy
Ozempic® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction or nonfatal stroke) in adults with type 2 diabetes mellitus and established CVD.
LEADER—A landmark CVOT for Victoza®1
9340
patients
Age ≥50 years and established CVD
OR
Age ≥60 years and risk factors for CVD


Cardiovascular standards of care
(antihypertensives, lipid-lowering agents, and antiplatelet therapy)

Diabetes standards of care
(lifestyle modification, OADs, and insulin)
Duration 3.5-5 years
Time to first major adverse cardiovascular event (MACE) composed of:
Composite primary endpoint

CV death

Nonfatal MI

Nonfatal stroke

- Prospectively designed and powered to assess noninferiority and then superiority
- Patients were titrated to maximum tolerated dose of 0.6 mg to 1.8 mg
- Median daily dose of Victoza® was 1.78 mg
Victoza® significantly reduced MACE in adults with T2D and established CVD1





Absolute risk reduction:
1.9%

Median time of exposure to treatment: 3.5 years.
Median daily dose of Victoza®: 1.78 mg.
The primary composite outcome occurred in fewer patients in the Victoza® group (608 of 4668 patients [13.0%]) than in the SOC group (694 of 4672 [14.9%]) (hazard ratio, 0.87; 95% confidence interval [CI], 0.78-0.97; P=0.01).
Results for all 3 components of the primary composite endpoint supported the use of Victoza® vs SOC alone

In the LEADER trial
Victoza® provided a life-saving benefit1
Secondary endpoint: Death from CV causes in adults with T2D and established CVD




Death from CV causes was a prespecified secondary endpoint.
Hazard ratio, 0.78 (95% CI, 0.66-0.93).
Median time of exposure to treatment: 3.5 years.
Median daily dose of Victoza®: 1.78 mg.

Absolute risk reduction
1.3%
Death from CV causes occurred in fewer patients in the Victoza® group (219 patients [4.7%]) than in the SOC group (278 [6.0%]) (hazard ratio, 0.78; 95% CI; 0.66-0.93).


Absolute risk reduction
1.4%
Death from all causes occurred in fewer patients in the Victoza® group (381 patients [8.2%]) than in the SOC group (447 patients [9.6%]) (hazard ratio, 0.85; 95% CI, 0.74-0.97).
CV=cardiovascular; CVOT=cardiovascular outcomes trial; MI=myocardial infarction; RRR=relative risk reduction; SOC=standard of care; T2D=type 2 diabetes.
LEADER study design1
A phase 3B, multicenter, international, randomized, double-blind, placebo-controlled study to assess the cardiovascular safety of Victoza®. Adult patients with type 2 diabetes at high risk for cardiovascular events (N=9340) were randomized to receive once-daily Victoza® (0.6 mg-1.8 mg once daily with all patients being titrated to 1.8 mg once daily) or placebo. The primary endpoint was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The trial was prospectively designed and powered to assess whether Victoza® was noninferior or superior to placebo when measuring effect on CV events. Patients received trial products in addition to standard of care treatments such as oral antidiabetic treatments, insulin, and antihypertensive, antiplatelet, and lipid-lowering therapies.