Optimized Basal-bolus insulin regimens in type 1 diabetes: insulin glulisine versus regular human insulin in combination with Basal insulin glargine.

OBJECTIVE

To compare the efficacy and safety of insulin glulisine (GLU), a new rapid-acting insulin analogue, injected 0 to 15 minutes before or immediately after meals, with regular human insulin (RHI), injected 30 to 45 minutes before meals.

METHODS

Patients with type 1 diabetes (N = 860) received once-daily insulin glargine and subcutaneous injections of either GLU (premeal or postmeal) or premeal RHI in this open-label, randomized, controlled, multicen-ter, parallel-group, 12-week study.

RESULTS

Baseline to endpoint changes in mean gly-cated hemoglobin (as A1c equivalents) (A1c) occurred in the premeal GLU, postmeal GLU, and premeal RHI groups (-0.26%, -0.11%, and -0.13%, respectively). The reduction in A1c was greater for the premeal GLU group in comparison with the RHI group (P = 0.02) and the post-meal GLU group (P = 0.006); no significant between-treatment difference was found for postmeal GLU versus RHI. Overall, blood glucose profiles were similar in all 3 treatment groups but were significantly lower for premeal GLU 2-hour postbreakfast measurements (premeal versus postmeal GLU, P = 0.0017; premeal GLU versus RHI, P = 0.0001) and 2-hour postdinner measurements (premeal GLU versus RHI, P = 0.0001; premeal versus postmeal GLU, P = 0.0137). Severe hypoglycemic episodes were comparable for premeal GLU, postmeal GLU, and pre-meal RHI groups (8.4%, 8.4%, and 10.1%, respectively). Body weight increased (+0.3 kg) in the RHI and premeal GLU groups; however, weight decreased in the postmeal GLU group (-0.3 kg; between-treatment difference, P = 0.03).

CONCLUSION

Better A1c reductions were obtained with premeal GLU, but postmeal administration of GLU was as safe and effective as premeal GLU or RHI in combination with insulin glargine and was not associated with weight gain.