Comparative trial between insulin glargine and NPH insulin in children and adolescents with type 1 diabetes mellitus

J Pediatr Endocrinol Metab. 2002 Apr;15(4):369-76. doi: 10.1515/jpem.2002.15.4.369.

Abstract

The objective of this study was to compare the efficacy and safety of insulin glargine, a long-acting insulin analog, with NPH insulin in children and adolescents with type 1 diabetes mellitus (T1DM). In a multicenter, open-label, randomized, 6-month study, 349 patients with TIDM, aged 5-16 years, received insulin glargine once daily or NPH insulin either once or twice daily, based on their prior treatment regimen. Although there was no significant difference between the NPH insulin and insulin glargine treatment groups with respect to baseline to endpoint change in HbA1c levels, fasting blood glucose (FBG) levels decreased significantly more in the insulin glargine group (-1.29 mmol/l) than in the NPH insulin group (-0.68 mmol/L, p = 0.02). The percentage of symptomatic hypoglycemic events was similar between groups; however, fewer patients in the insulin glargine group reported severe hypoglycemia (23% vs 29%) and severe nocturnal hypoglycemia (13% vs 18%), although these differences were not statistically significant (p = 0.22 and p = 0.19, respectively). Fewer serious adverse events occurred in the insulin glargine group than in the NPH insulin group (p < 0.02). A once-daily subcutaneous dose of insulin glargine provides effective glycemic control and is well tolerated in children and adolescents with T1DM.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Age of Onset
  • Blood Glucose / metabolism
  • Child
  • Child, Preschool
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Double-Blind Method
  • Drug Hypersensitivity / physiopathology
  • Female
  • Glycated Hemoglobin A / analysis
  • Humans
  • Hyperglycemia / blood
  • Hyperglycemia / chemically induced
  • Insulin / adverse effects
  • Insulin / analogs & derivatives*
  • Insulin / therapeutic use*
  • Insulin Glargine
  • Insulin, Isophane / adverse effects
  • Insulin, Isophane / therapeutic use*
  • Insulin, Long-Acting
  • Male
  • Multicenter Studies as Topic
  • Puberty / physiology

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Insulin
  • Insulin, Long-Acting
  • Insulin Glargine
  • Insulin, Isophane