Insulin Glargine Versus Intermediate-Acting Insulin as the Basal Component of Multiple Daily Injection Regimens for Adolescents with Type 1 Diabetes Mellitus
Received 3 August 2007; received in revised form 2 April 2008; accepted 24 April 2008. published online 01 July 2008.
Objectives
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).
Study design
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.
Results
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.
Conclusions
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.
aBarbara Davis Center, University of Colorado, Aurora, CO
bDepartment of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA
cDepartment of Pediatrics, Washington University School of Medicine and St. Louis Children's Hospital, St. Louis, MO
dDepartment of Pediatrics and the Yale Center for Clinical Investigation, Yale University School of Medicine, New Haven, CT
Reprint requests: Dr H. Peter Chase, Barbara Davis Center, University of Colorado, Mail Stop A140, PO Box 6511, Aurora, CO 80045-6511
Supported by the sanofi-aventis US Group. Chase and White have served on the sanofi-aventis US Medical Advisory Board. Arslanian has received research grant support from and has served on the sanofi-aventis US Advisory Board. Tamborlane has served on the sanofi-aventis US and Novo Nordisk Advisory Boards. The authors had full access to the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
ABSTRACT