Ritzel R, Harris SB, Baron H et al (2018) A randomized controlled trial comparing efficacy and safety of insulin glargine 300 units/mL versus 100 units/mL in older people with type 2 diabetes: results from the SENIOR study. Diabetes Care 41: 1672–80
- SENIOR was a multicenter, phase 3b, open-label, randomised controlled trial comparing insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in older people (age ≥65 years) with type 2 diabetes.
- In total, 1014 participants, including a subgroup of 241 people aged ≥75 years, were randomised to one of the two glargine preparations. Insulin doses were adjusted regularly to achieve a self-monitored plasma glucose target of 5.0–7.2 mmol/L.
- After 6 months of treatment, mean HbA1c was reduced from 66 to 56 mmol/mol (8.2% to 7.3%) in both treatment groups, with Gla-300 meeting its primary non-inferiority endpoint. Similar findings were observed in the ≥75-year-old subgroup.
- Overall, there was no significant difference in rates of the secondary endpoint of confirmed or severe hypoglycaemia between the treatment groups (59% vs 62.7% in the Gla-300 and Gla-100 groups, respectively), although a trend toward lower rates with Gla-300 was observed at the lower hypoglycaemia threshold of <3.0 mmol/L.
- In the ≥75-year-old subgroup, in general the rates of hypoglycaemia were similar to that of the overall cohort; however, the incidence of documented symptomatic hypoglycaemia (<3.0 mmol/L) was significantly lower in the Gla-300 group (1.5% vs 10.4%; relative risk, 0.33; 95% confidence interval, 0.12–0.88).
- This study is limited by its open-label design and the relatively small number of hypoglycaemic events that occurred.