Comparison of the efficacy and safety of insulin glulisine and insulin lispro combined with insulin glargine in patients with diabetes

Objective To compare the efficacy and safety of insulin glulisine and insulin lispro combined with insulin glargine in patients with diabetes mellitus. Methods This was a multi-centre randomly controlled study. Thirty four patients with type 1 and 450 patients with type 2 diabetes mellitus with a HbA1c level of 6.5% to 11.0% and more than 3 months of continuous insulin treatment immediately prior to study entry were enrolled from February 2007 to June 2008. After 4-week run-in period with insulin lispro (three times a day, 0-15 min before the meals) combined with insulin glargine treatment (once daily before breakfast) , all the subjects were randomized (3∶1) to receive a 12-week treatment with insulin glulisine or insulin lispro in combination with insulin glargine. The data collected at the visit after the 4-weeks run-in period was defined as the baseline data. The change in HbA1c, blood glucose, treatment satisfaction and incidence of hypoglycemia after the treatment was recorded and compared. The data of the two groups were compared by using an ANOVA model. Results After 12-week of treatment, HbA1c reduced from 8.7%±1.2% to 7.9%±1.0% in insulin glulisine group, and from 8.8%±1.2% to 7.9%±1.0% in insulin lispro group (compared with baseline, t=-12.55 and -8.88, both P 0.05). The incidence of all categories of symptomatic hypoglycemia was comparable between the two groups (33.9% vs 34.7%) during treatment period. An increase of satisfaction scores after treatment was found both in the insulin glulisine group (from 29±5 to 31±5, t=6.81 P<0.05) and insulin lispro group (from 29±5 to 31±4, t=4.21, P<0.05). Conclusions It showed that when used in combination with insulin glargine, insulin glulisine is clinical equivalent to insulin lispro in decreasing HbA1c and plasma glucose in Chinese patients with diabetes mellitus. Both regimens are well tolerated and safe. Key words: Diabetes mellitus; Insulin glulisine; Insulin lispro