Background and Aims

In BRIGHT (NCT02738151), Gla-300 showed similar glycaemic improvements to IDeg over 24 weeks in insulin-naïve participants with T2DM, with 24h hypoglycaemia incidence and rates being comparable between treatments during the maintenance and full-study periods, but lower with Gla-300 during the titration period. Older age and impaired renal function can increase hypoglycaemia risk; we evaluated the impact of baseline age and renal function on glycaemic and hypoglycaemia outcomes in BRIGHT.

Methods

BRIGHT was an open-label, actively-controlled, parallel-group trial in people with T2DM randomised to Gla-300 (N=466) or IDeg (N=463). This post-hoc analysis evaluated HbA_1c change and incidence and rates of 24h confirmed (≤3.9mmol/L [≤70mg/dL]) hypoglycaemia over 24 weeks, by age and renal function subgroups.

Results

HbA_1c reduction was greater with Gla-300 versus IDeg in participants ≥70 years, with significant heterogeneity of treatment effect between ≥70 and <70 years subgroups (p=0.0087). Hypoglycaemia incidence and rates were similar between treatments in both groups. Significant heterogeneity of treatment effect across renal function groups for HbA_1c reduction (p=0.015) reflected greater HbA_1c reduction with Gla-300 versus IDeg in patients with impaired renal function (eGFR <60 mL/min/1.73m²). Hypoglycaemia incidence was similar with Gla-300 and IDeg across all eGFR subgroups. Hypoglycaemia rates were similar between treatments in participants with eGFR <60 mL/min/1.73m², though lower with Gla-300 versus IDeg in those with normal renal function (eGFR ≥90 mL/min/1.73m²).

Conclusions

In people with T2DM at high risk of hypoglycaemia (≥70 years, impaired renal function), Gla-300 provided greater reductions in HbA_1c versus IDeg, without increased incidence or rates of hypoglycaemia.

Study sponsored by Sanofi