Comparison of insulin lispro protamine suspension versus insulin glargine once daily in basal-bolus therapies with insulin lispro in type 2 diabetes patients: a prospective randomized open-label trial
Diabetes, Obesity and Metabolism, 11/04/2011
Koivisto V et al. – A basal–bolus regimen with insulin lispro protamine suspension (ILPS) once daily resulted in non–inferior glycaemic control compared to a similar regimen with glargine, without statistically significant or clinically relevant differences in hypoglycaemia. ILPS–based regimens can be considered an alternative to basal–bolus regimens with glargine for type 2 diabetes mellitus (T2DM) patients.
Methods- Three hundred eighty–three insulin–treated patients were randomized to either ILPS plus lispro or glargine plus lispro in this open–label 24–week European study.
- Insulin doses were titrated to predefined blood glucose (BG) targets.
- Non–inferiority of ILPS versus glargine was assessed by comparing the upper limit of the 95% confidence interval (CI) for the change of HbA1c from baseline to week 24 (adjusted for country and baseline HbA1c) with the non–inferiority margin of 0.4%.
- Secondary endpoints included HbA1c categories, BG profiles, insulin doses, hypoglycaemic episodes, adverse events and vital signs.
- Non–inferiority of ILPS versus glargine in the change of HbA1c from baseline was shown: least–square mean between–treatment difference (95% CI) was 0.1% (–0.11; 0.31).
- Mean changes at week 24 were –1.05% (ILPS) and –1.20% (glargine).
- HbA1c <7.0% was achieved by 21.7 versus 29.4% of patients.
- Mean basal/mealtime insulin doses at week 24 were 29.6/36.2 IU/day (ILPS) versus 32.8/42.2 IU/day (glargine); the difference was not statistically significant for total dose (p=0.7).
- In both groups, 56.1/25.7% versus 63.6/19.3% of patients experienced any/nocturnal hypoglycaemia (p=0.2 for both).
- No relevant differences were noted in any other variables.
