Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve individuals according to diabetes duration: Results from the REALI European pooled data analysis

Diabetes Obes Metab. 2025 Jan;27(1):228-237. doi: 10.1111/dom.16008. Epub 2024 Oct 17.

Abstract

Aim: To evaluate the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiation according to diabetes duration (DD).

Materials and methods: We analysed patient-level data from 2381 insulin-naïve individuals with type 2 diabetes (T2D), of whom 2349 (98.7%) were treated with Gla-300 for 24 weeks. Of the 2381 participants, 1048 (44.0%) had a DD of less than 8 years and 1333 (56.0%) had a DD of 8 years or longer. We further analysed the subgroups of participants having a DD of less than 4 years (N = 450), 4-8 years (N = 598), 8-12 years (N = 627) and 12 years or longer (N = 706).

Results: Mean ± standard deviation age was 60.2 ± 9.0 years in participants with a DD less than 8 years and 64.2 ± 8.8 years in those with a DD of 8 years or longer. At 24 weeks of Gla-300 therapy, HbA1c improved with a least-squares (LS) mean change from baseline of -1.88% (95% confidence interval [CI], -1.95 to -1.80) and -1.71% (95% CI, -1.77 to -1.65), respectively, resulting in a LS mean difference between groups of 0.17% (95% CI, 0.07 to 0.26; P = .0005). In the subgroup analysis, LS mean HbA1c reduction from baseline to week 24 was highest in participants with a DD of less than 4 years and lowest in participants with a DD of 12 years or longer. Overall, incidences of symptomatic and severe hypoglycaemia were low, irrespective of DD, without body weight changes.

Conclusions: Gla-300 was effective and safe in insulin-naïve individuals with T2D, regardless of DD. Improvement in HbA1c was greater when Gla-300 was initiated in participants with a DD of less than 4 years, although the difference between the groups was modest.

Keywords: Gla‐300; diabetes duration; insulin glargine 300 U/mL; insulin‐naïve; type 2 diabetes.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Blood Glucose / drug effects
  • Diabetes Mellitus, Type 2* / blood
  • Diabetes Mellitus, Type 2* / drug therapy
  • Europe / epidemiology
  • Female
  • Glycated Hemoglobin* / analysis
  • Glycated Hemoglobin* / metabolism
  • Humans
  • Hypoglycemia* / chemically induced
  • Hypoglycemia* / epidemiology
  • Hypoglycemic Agents* / administration & dosage
  • Hypoglycemic Agents* / adverse effects
  • Hypoglycemic Agents* / therapeutic use
  • Insulin Glargine* / administration & dosage
  • Insulin Glargine* / adverse effects
  • Insulin Glargine* / therapeutic use
  • Male
  • Middle Aged
  • Time Factors
  • Treatment Outcome

Substances

  • Insulin Glargine
  • Hypoglycemic Agents
  • Glycated Hemoglobin
  • Blood Glucose
  • hemoglobin A1c protein, human

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