At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus
- ✓Age ≥50 years at screening with clinical evidence of cardiovascular disease, OR age ≥60 years at screening with subclinical evidence of cardiovascular disease
- ✓HbA1c ≥7.0% at screening
- ✓Antidiabetic treatment status: drug-naïve, or on 1-2 oral agents, or on basal/long-acting insulin analogue/pre-mixed insulin alone or with 1-2 oral agents
- ✕Type 1 diabetes mellitus
- ✕Prior GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days before screening
- ✕Prior DPP-IV inhibitor within 30 days before screening
- ✕Insulin other than basal, long-acting analogue, or pre-mixed insulin within 90 days before screening (except short-term for intercurrent illness)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
In Brief
A Phase 3 clinical trial evaluating semaglutide and placebo for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 3,297 participants across 253 sites in 21 countries.
Detailed 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.
Study Details
Timeline
Interventions
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)
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)
Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).