- Add-on insulin degludec/liraglutide to sodium-glucose cotransporter-2 inhibitor was superior and non-inferior to insulin glargine in patients with uncontrolled type 2 diabetes mellitus (T2DM).
Why this matters
- Previous cost-effectiveness analysis showed lower cost of treatment with insulin degludec/liraglutide per patient.
- DUAL IX trial: 26-week, phase 3b, open-label, parallel-group, multinational, treat-to-target trial.
- 210 insulin-naïve patients with uncontrolled T2DM were randomly assigned to add-on insulin degludec/liraglutide or insulin glargine to sodium-glucose cotransporter-2 inhibitor therapy.
- Primary endpoint: change in HbA1c.
- Funding: Novo Nordisk.
- Insulin degludec/liraglutide was non-inferior to insulin glargine in terms of mean HbA1c reduction (1.9 vs 1.7% points; P<.0001 superiority was also confirmed in hba1c change points ci to>
- Insulin degludec/liraglutide was also superior in terms for:
- body weight (mean difference, −1.92 kg; 95% CI, −2.64 to −1.19);
- severe or blood-glucose-confirmed symptomatic hypoglycaemia (rate ratio, 0.42; 95% CI, 0.23-0.75) and
- total daily insulin dose (mean difference, −15.37 units; 95% CI, −19.60 to −11.13).
- Treatment-emergent adverse event rate was 61.7% with insulin degludec/liraglutide and 58.6% with insulin glargine.
- Insulin degludec/liraglutide treatment increased lipase levels and nausea incidence.
- Open-label design.