Completed
PHASE3
INTERVENTIONAL
NCT01720446
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
semaglutide
Type:
DRUG
Description:
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)
Name:
semaglutide
Type:
DRUG
Description:
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)
Name:
placebo
Type:
DRUG
Description:
Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
Primary Outcomes
Measure:
Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
TimeFrame:
Time from randomisation up to end of follow-up (scheduled at week 109)
Description:
Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Trial Information
NCT ID
NCT01720446
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025