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

ABSTRACT: Abstract SENIOR was a phase 3b, randomized, open-label, 2-arm, parallel-group, multicenter, 30-week trial. Randomization was stratified by screening HbA1c (<8.0 vs ?8.0 %), previous insulin use (Yes/No), and sulfonylurea or meglitinide use at screening (Yes/No). Insulin was titrated to the ADA-recommended glycemic target for healthy elderly individuals (fasting SMPG: 90–130?mg/dL [5.0–7.2 mmol/L]), a higher glycemic target than utilized previously in randomized controlled trials of insulin glargine 300?U/mL (Gla-300) versus 100?U/mL (Gla-100) in adults. The aim of the SENIOR trial was to compare the efficacy and safety of Gla-300 with Gla-100. In total, 1014 individuals (?65 years) 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] %). Similar percentages of participants in both groups reported confirmed (?70?mg/dL [?3.9 mmol/L]) or severe hypoglycemia. The annualized rates of documented symptomatic (?70?mg/dL [?3.9 mmol/L]) 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. 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. Supported By: Sanofi (clinicaltrials.gov NCT02320721)

SUBMITTER: Ritzel R 

PROVIDER: S-EPMC6185084 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature