- IDegLira was determined to be superior to IGlar U100 as an add-on to sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy based on measures of glycemic control, body weight, hypoglycemia rate, total daily insulin dose, and treatment management outcomes.
Why this matters
- IDegLira, a fixed-ratio combination of insulin degludec (IDeg), long-acting basal insulin, and the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide, has demonstrated significantly greater reductions in HbA1c compared with the individual components liraglutide and IDeg alone.
- DUAL IX phase 3b, 26-week, open-label trial of 420 patients with uncontrolled T2D receiving SGLT2i±oral antidiabetic drugs.
- Participants were randomly assigned 1:1 to receive add-on IDegLira or IGlar U100 (100 U/mL). Doses were titrated twice weekly to a fasting glucose target of 72-90 mg/dL; only IDegLira had a maximum dose (50 U).
- 5-domain treatment-related impact measure-diabetes questionnaire used to quantify patient’s perspective.
- Mean A1C decreased from 8.2% at baseline to 6.3% at week 26 for IDegLira, and from 8.4% to 6.7% for IGlar U100 (P<.0001>
- The rate of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycemic episodes was 58% lower (P=.0035) with IDegLira (0.37 events/patient-year of exposure) vs IGlar U100 (0.90).
- Adverse event rates were low in both treatment groups with no unexpected safety issues.
- Questionnaire: help to avoid hyperglycemia: estimated treatment ratio, 1.95 (95% CI, 1.32-2.87); help to avoid hypoglycemia: estimated treatment ratio, 1.62 (95% CI, 1.12-2.36).
- Post hoc analysis from a defined and limited time frame of 52 weeks.