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

Gourdy, P; Bonadonna, RC; Mauricio, D; Müller-Wieland, D; Mauquoi, C; Vera, C; Bonnemaire, M; Freemantle, N

doi:10.1111/dom.16008

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 MetabPublished 17 Oct 2024Pooled patient-level analysis of real-world studies (REALI) by diabetes duration

Primary result · HbA1c LS mean change from baselineResultLS mean difference 0.17 % 95% CI 0.07–0.26

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Authors' conclusion

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.

Study context

Population: Insulin-naïve individuals with T2D initiating insulin glargine 300 U/mL (Gla-300)2,349 treated for 24 weeks
Participants: 2,381 individuals

Comparison: Gla-300 initiation in diabetes duration (DD) <8 years vs DD ≥8 years
DD <8 yearsn = 1,048reference
DD ≥8 yearsn = 1,333
DD <4 yearsn = 450
DD 4-8 yearsn = 598
DD 8-12 yearsn = 627
DD ≥12 yearsn = 706
Primary endpoint: HbA1c change from baseline
Follow-up: 24 weeks

Methodological detailsEuropean pooled data, subgroup analysis by DD

European pooled data
Subgroup analysis by DD

Primary result

HbA1c LS mean change from baseline

Least-squares (LS) mean difference

0.17 %

95% CI 0.07–0.26

P = 0.0005

Change by group

DD <8 years

−1.88

LS mean change · 95% CI −1.95–-1.80 · %

DD ≥8 years

−1.71

LS mean change · 95% CI −1.77–-1.65 · %

DD ≥8 yearsvs DD <8 years

LS mean difference 0.17 % (95% CI 0.07–0.26); P = 0.0005

As reported in the abstract

Further findings

HbA1c reduction by DD subgroup (<4, 4-8, 8-12, ≥12 years) · baseline to week 24

LS mean HbA1c reduction highest with DD <4 years and lowest with DD ≥12 years

Safety

Incidences of symptomatic and severe hypoglycaemia low irrespective of DD, without body weight changes

Original publication

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. Published 17 October 2024. doi:10.1111/dom.16008

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