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.
Pierre Gourdy, Riccardo C Bonadonna, Didac Mauricio, Dirk Müller-Wieland, Celine Mauquoi, Carine Vera, Mireille Bonnemaire, Nick Freemantle
Author Information
Pierre Gourdy: Endocrinology, Diabetology and Nutrition Department, Toulouse University Hospital, Toulouse, France. ORCID
Riccardo C Bonadonna: Azienda Ospedaliero-Universitaria di Parma, Department of Medicine and Surgery, University of Parma, Parma, Italy.
Didac Mauricio: Department of Endocrinology and Nutrition, CIBERDEM, Hospital de la Santa Creu i Sant Pau Institut de Recerca, Barcelona, Spain. ORCID
Dirk Müller-Wieland: Department of Medicine I, University Hospital Aachen, Aachen, Germany. ORCID
Celine Mauquoi: IDDI, Louvain-la-Neuve, Belgium.
Carine Vera: IVIDATA, Paris, France.
Mireille Bonnemaire: General Medicines, Sanofi, Paris, France.
Nick Freemantle: Institute of Clinical Trials and Methodology, University College London, London, UK. ORCID
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.
