Efficacy and Hypoglycaemia Outcomes With Once‐Weekly IcoSema Versus Comparators in Individuals With Type 2 Diabetes by Kidney and Liver Function: A Post Hoc Analysis of the COMBINE 1–3 Trials
Authors' conclusion
Efficacy and hypoglycaemia outcomes with IcoSema versus comparators were generally consistent among adults with T2D with mild to moderate kidney impairment or impaired liver function.
Study context
- Population
- Adults with T2D, by kidney (eGFR ≥90; 60–<90; 30–<60; <30 mL/min/1.73 m²) and liver (total bilirubin ≤21 μmol/L or AST ≤31/≤37 [female/male] U/L vs higher) function subgroupsCOMBINE 1–3
- Comparison
- Once-weekly IcoSema vs comparators
Methodological detailssubgroup analysis by kidney and liver function
- Subgroup analysis by kidney and liver function
Primary result
As reported in the abstract
Treatment by kidney/liver function subgroup interactions: change in HbA1c, change in body weight, rates of clinically significant or severe hypoglycaemia · baseline to week 52
- No statistically significant treatment by subgroup interactions for change in HbA1c, body weight or combined clinically significant or severe hypoglycaemia rates (hypoglycaemia not assessed by kidney function for COMBINE 2)
- all p > 0.05
Further findings
HbA1c <7.0% without weight gain and without clinically significant or severe hypoglycaemia
- Significant treatment by kidney function subgroup interaction in COMBINE 3, not COMBINE 1 or 2
- P < 0.05
- Significant treatment by liver function subgroup interaction in COMBINE 1, not COMBINE 2 or 3
- P < 0.05
Mean weekly total insulin dose
- COMBINE 1 and 3: significant treatment by kidney function subgroup interactions; no significant treatment by liver function subgroup interactions
Original publication
Efficacy and Hypoglycaemia Outcomes With Once‐Weekly IcoSema Versus Comparators in Individuals With Type 2 Diabetes by Kidney and Liver Function: A Post Hoc Analysis of the COMBINE 1–3 Trials. Diabetes Obes Metab. Published 5 August 2026. doi:10.
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