A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes

OBJECTIVE - To determine the safety and efficacy of the long-acting insulin analog, insulin glargine, as a component of basal bolus therapy in patient s with type I diabetes. RESEARCH DESIGN AND METHODS - Patients with type 1 diabetes receiving basal -bolus insulin treatment with NPH human insulin and insulin lispro mere ran domized to receive insulin glargine (HOE 901), a long-acting basal insulin analog, once a day (n = 310) or NPH human insulin (n = 309) as basal treatm ent with continued bolus insulin lispro for 16 weeks in an open-label study NPH insulin patients maintained their prior schedule of administration onc e or twice a day, whereas insulin glargine patients received basal insulin once a day at bedtime. RESULTS - Compared with all NPH insulin patients, insulin glargine patients had significant decreases in fasting blood glucose measured at home (means +/- SEM, -42.0 +/- 4.7 vs. - 12.4 +/- 4.7 mg/dl [-2.33 +/- 0.26 vs. -0.69 +/- 0.26 mmol/l]; P = 0.0001). These differences were evident early and per sisted throughout the study. More patients in the insulin glargine group (2 9.6%) than in the NPH group (16.8%) reached a target fasting blood glucose of 119 mg/dl. (<6.6 mmol/l). However, there were no differences between the groups with respect to change in GHb. Insulin glargine treatment was also associated with a significant decrease in the variability of fasting blood glucose values (P = 0.0124). No differences in the occurrence of symptomati c hypoglycemia, including nocturnal hypoglycemia, were observed. Overall, a dverse events were similar in the two treatment groups with the exception o f injection site pain, which was more common in the insulin glargine group (6.1%) than in the NPH group (0.3%). Weight gain was 0.12 kg in insulin gla rgine patients and 0.54 kg in NPH insulin patients (P = 0.034). CONCLUSIONS - Basal insulin therapy with insulin glargine once a day appear s to be as safe and at least as effective as using NPH insulin once or twic e a day in maintaining glycemic control in patients with type 1 diabetes re ceiving basal-bolus insulin treatment with insulin lispro.