Lispro Vs. Detemir in Insulin-Naive Type 2 Diabetes Patients

Lispro comes out ahead with lower A1c results, but….

Insulin lispro protamine suspension (ILPS) and insulin detemir were compared in insulin-naive patients with Type 2 diabetes poorly controlled by oral glucose-lowering agents (OGLAs) to demonstrate non-inferior overall glycemic control.

This was a 24-week, multinational, open-label, parallel-group, treat-to-target trial. Adults taking two or more OGLAs were randomized to ILPS (n = 223) or detemir (n = 219) once daily at bedtime. Doses were titrated to target fasting blood glucose (FBG) 5.0–7.2 mmol/l. A pre-breakfast dose was added up to week 8 per prespecified criteria. The primary objective was comparison of glycated hemoglobin (HbA_1c) change from baseline (non-inferiority margin 0.4%).

At end-point, HbA_1c decreased from 8.8 ± 0.7% in both groups to 7.3 ± 0.9% (ILPS) and 7.5 ± 1.1% (detemir). Least-squares mean difference (95% confidence interval) for HbA_1c and glycemic variability demonstrated non-inferiority. End-point mean FBG was 7.0 vs. 6.9 mmol/l, and percentages of patients achieving H < 7.0% were 34.9% vs. 31.2% for ILPS vs. detemir. More ILPS patients used twice-daily dosing (59% vs. 49%). Mean daily insulin dose was 0.39 vs. 0.46 U/kg and weight gain was 1.88 vs. 0.36 kg for ILPS vs. detemir. Overall hypoglycemia and nocturnal rates were higher for ILPS.

From the results it was conclude that at end-point, ILPS was non-inferior to detemir in HbA_1c change from baseline. Patients using ILPS achieved lower end-point HbA_1c with lower insulin doses but greater hypoglycaemia and weight gain.