Insulin Glargine Versus Intermediate-Acting Insulin as the Basal Component of Multiple Daily Injection Regimens for Adolescents with Type 1 Diabetes Mellitus

Abstract

To compare long-acting insulin glargine (Lantus) with intermediate-acting insulin (neutral protamine Hagedorn [NPH]/Lente) when used as the basal component of a multiple daily injection (MDI) regimen with prandial insulin lispro (Humalog) in adolescents with type 1 diabetes mellitus (T1DM). This was an active-controlled, randomized, open-label, sex-stratified, 2-arm, parallel-group comparison of once-daily insulin glargine with twice-daily NPH/Lente in an MDI regimen. Changes in glycated hemoglobin A1C (A1C), occurrence of hypoglycemia, and adverse events were assessed in 175 patients (age 9 to 17 years) with T1DM. The overall mean change in A1C from baseline to week 24 was similar in the 2 groups: insulin glargine (n = 76), -0.25% +/- 0.14%; NPH/Lente (n = 81), 0.05% +/- 0.13% (P = .1725). However, an analysis of covariance, adjusting for baseline A1C, revealed a strong study arm effect on the slopes of the regression lines, indicating that the reduction in A1C was significantly greater with insulin glargine in those patients with higher baseline A1C values. The rate of confirmed glucose values <70 mg/dL was higher in the patients receiving insulin glargine (P = .0298). No differences in the rate of severe hypoglycemia (P = .1814) or the occurrence of glucose levels <50 mg/dL (P = .82) or <36 mg/dL (P = .32) were found between the 2 groups. Insulin glargine is well tolerated in MDI regimens for pediatric patients with T1DM and may be more efficacious than NPH/Lente in those with elevated A1C.