SUSTAIN-6: Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes

Background + significance

SUSTAIN-6 was the cardiovascular outcomes trial (CVOT) that established semaglutide as cardioprotective in type 2 diabetes — a major regulatory and clinical landmark. The 26% MACE reduction expanded the indication for Ozempic to include cardiovascular risk reduction in T2D with established CV disease.

Trial design

Sponsor

Novo Nordisk

Phase

Phase 3

Participants

3,297

Duration

104 weeks

ClinicalTrials.gov ID

NCT01720446

Drugs tested

• Ozempic (semaglutide 0.5/1.0 mg)Active

Primary outcome

Time to first major adverse cardiac event (composite: CV death, non-fatal MI, non-fatal stroke)

26% relative reduction in MACE on semaglutide vs placebo (HR 0.74, 95% CI 0.58-0.95; P=0.02 for non-inferiority and superiority)

Secondary outcomes

• •Significant reduction in non-fatal stroke (HR 0.61)
• •Numerical reduction in non-fatal MI (HR 0.74)
• •A1C reduction 1.1-1.4 percentage points
• •Mean body-weight reduction 3.6-4.9 kg

Why it matters

1. 1.First CVOT demonstrating GLP-1 cardiovascular benefit in T2D.
2. 2.Led to expanded Ozempic indication (CV risk reduction).
3. 3.Set the stage for SELECT (semaglutide CV benefit in obesity without diabetes).