A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

NCT03914326 · Completed

Last updated 2026-05-28

This clinical trial is testing the medication semaglutide in adults with type 2 diabetes to see how it affects the risk of heart-related events like heart attacks or strokes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 9,651 people

Who can join Ages 50+ · all sexes

Timeline Started 2019-06 · est. completion 2024-08

Where 492 sites · Algeria, Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czechia, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT03914326 ↗

Description as written by the study sponsor.

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Treatments tested

Semaglutide Drug

Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state
Placebo (semaglutide) Drug

Placebo tablets to be taken with water at the same time every morning in a fasting state

Main thing measured	Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03914326 ↗