INSULIN GLARGINE 300 U/ML VS. 100 U/ML IN OLDER PEOPLE WITH T2DM: RESULTS FROM A RANDOMIZED TRIAL

Abstract

Background and Aims: The SENIOR trial compared the efficacy and safety of Gla-300 with Gla-100 in adults aged ≥65 years. Method: SENIOR was a phase 3b, randomized, open-label, 2-arm, parallel-group, multicenter, 30-week trial. Insulin was titrated to theADA-recommended glycemic target for healthy elderly individuals (fasting SMPG: 90-130mg/dL [5.0-7.2mmol/L]), a higher glycemic target than utilized previously in randomized controlled trials of Gla-300 versus Gla-100 in adults. Results: In total, 1014 individuals ≥65 years of age with T2DM were included in the trial, of whom 241 were ≥75 years old. The primary endpoint of non-inferiority of mean change in HbA1c for Gla-300 versus Gla-100 was achieved (least squares mean difference [95% CI]: 0.02, [-0.092 to 0.129] %). Overall, similar percentages of participants in both treatment groups reported confirmed (≤70 mg/dL) or severe hypoglycemia. The annualized rates of documented symptomatic (≤70 mg/dL) hypoglycemia were lower with Gla-300 versus Gla-100, both in the overall study population (1.85 vs 2.56 events/participant-year; rate ratio [RR] 0.74 [0.56 to 0.96]) and in the ≥75 years subpopulation (1.12 vs 2.71 events/participant-year; RR 0.45 [0.25 to 0.83]). Frequency of adverse events, including cardiovascular events, falls and fractures was similar between treatments in both the overall population and participants ≥75 years of age. Conclusion: These results indicate that Gla-300 was effective in older people with T2DM, with a good safety profile, resulting in comparable reductions in HbA1c and lower rates of documented symptomatic hypoglycemia versus Gla-100.