Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

NCT01720446 · Completed

Last updated 2026-05-28

This trial tested the long-term effects of semaglutide in adults with type 2 diabetes to see how it impacts heart health and other serious health outcomes.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 3,297 people

Who can join Ages 50+ · all sexes

Timeline Started 2013-02 · est. completion 2016-03

Where 253 sites · Algeria, Argentina, Australia, Brazil, Bulgaria, Canada, Denmark, Germany, India, Israel, Italy, Malaysia, Mexico, Poland, Russia, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT01720446 ↗

Description as written by the study sponsor.

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

Treatments tested

semaglutide Drug

Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
semaglutide Drug

Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
placebo Drug

Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).

Main thing measured	Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01720446 ↗