Aims:
We aimed to evaluate if level of glycaemic control, age, or being insulin naïve affected the risk of hypoglycaemia (defined by BG < 3 mmol/L) during IGlar self-titration.
Materials and methods:
We performed exploratory analyses of pooled treatment groups, statistically equivalent in ELEMENT-2 (double-blind) and ELEMENT-5 (open label)[Phase 3 studies of LY IGlar vs. Lantus®]. Hypoglycaemia at Weeks 8 and 12 (titration phase) and at Week 24 (maintenance phase) was analysed by category of HbA1c (< 7%, 7 – 8.5%, > 8.5%), and subgroups of age (< 65, ≥65yrs) and previous insulin use (naïve or not).ANOVA was used for baseline analyses and ANCOVA or MMRM for post-baseline analyses, with a significance level of = 0.05.
Results:
In ELEMENT-2 (N = 756), 50.0% were male, 28.3% ≥65yrs of age, 60.4% insulin naïve, and 83.3% on sulfonylureas; baseline HbA1c was 8.33%± 1.08%. In ELEMENT-5(N = 493), 52.1% were male, 21.3% ≥65yrs of age, 45.2% insulin naïve, and 84.0% on sulfonylureas; baseline HbA1c was 8.61%± 1.06%.
In ELEMENT-5, patients with HbA1c > 8.5% had lower rates and incidences of hypoglycaemia throughout the study. In both studies, patients ≥65yrs of age had lower baseline HbA1c, smaller dose increases with the same hypoglycaemia frequency compared to patients < 65yrs of age, with no differences in HbA1c post-baseline.
Conclusions:
The risk of total hypoglycaemia was similar among new and prior users of basal insulin. Hypoglycaemic risk was not higher among older patients and increases as HbA1c approaches 7%; therefore, mitigation is prudent as HbA1c improves.
