Ritzel R, et al. - The efficacy and safety of insulin glargine 300 units/mL (Gla-300) vs glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes were determined in the SENIOR study. In older people with type 2 diabetes, Gla-300 was shown to be effective and safe. It resulted in comparable reductions in HbA_1c and similarly low or lower risk of documented symptomatic hypoglycemia vs Gla-100. Participants aged ≥75 years demonstrated a significant benefit in hypoglycemia reduction.

Methods

• Researchers performed SENIOR study.
• This study was an open-label, two-arm, parallel-group, multicenter phase 3b trial designed to enroll ~20% of participants aged ≥75 years.
• They performed randomization of 1,014 participants (1:1) to Gla-300 or Gla-100, titrated to a fasting self-monitored plasma glucose of 5.0–7.2 mmol/L (90–130 mg/dL).

Results

• Mean age of the participants was 71 years.
• Gla-300 (-0.89%) and Gla-100 (-0.91%) resulted in comparable reductions in HbA_1c from baseline to week 26 in the overall population (least squares mean difference: 0.02% [95% CI -0.092 to 0.129]); participants aged ≥75 years also demonstrated comparable reductions in HbA_1c from baseline to week 26 (-0.11% [-0.330 to 0.106]).
• Both treatment groups showed low and similar incidence and rates of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia events; lower rates of documented symptomatic hypoglycemia were observed with Gla-300.
• With Gla-300 vs Gla-100, the lower risk of hypoglycemia was more apparent in the subgroup aged ≥75 years vs the overall population.
• They observed significantly lower annualized rates of documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) hypoglycemia(Gla-300: 1.12; Gla-100: 2.71; rate ratio: 0.45 [95% CI 0.25–0.83]).