Basal insulin glargine (HOE 901) versus NPH insulin in patients with type 1 diabetes on multiple daily insulin regimens. U.S. Insulin Glargine (HOE 901) Type 1 Diabetes Investigator Group.

Abstract

OBJECTIVE: Insulin glargine (HOE 901, 21(A)-Gly-30(B)a-L-Arg-30(B)b-L-Arg human insulin) is a novel recombinant analog of human insulin with a shift in the isoelectric point producing a retarded absorption rate and an increased duration of action that closely mimics normal basal insulin secretion. It recently received approval from the Food and Drug Administration. The aim of this study was to evaluate 2 formulations of insulin glargine for safety and efficacy in the treatment of patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: In a 4-week trial, 256 patients with type 1 diabetes received either NPH insulin or insulin glargine containing 30 microg/ml zinc (insulin glargine[30]) or 80 microg/ml zinc (insulin glargine[80]). Insulin glargine was given subcutaneously once daily at bedtime. NPH insulin was given either once daily (at bedtime) or twice daily (before breakfast and at bedtime), according to the patient's prestudy regimen. The initial doses of insulin glargine and NPH were based on the previous NPH total daily dose. RESULTS: At study end point, insulin glargine-pooled groups had significantly lower fasting plasma glucose (FPG) levels than the NPH insulin group, with adjusted mean FPG levels reduced by 2.2 mmol/l (P = 0.0001). Insulin glargine was superior to NPH insulin in reducing FPG levels in patients who had previously received NPH insulin twice daily but not in patients who had previously received NPH once daily. FPG levels were more stable in patients using insulin glargine than in patients using NPH insulin. A subset of patients (n = 71) underwent hourly overnight plasma glucose measurements. Insulin glargine patients exhibited lower FPG levels after 5:00 A.M.; the difference was significant by 8:00 A.M. The adjusted mean FPG for insulin glargine[30] was 7.8 mmol/l; for insulin glargine[80], 7.3 mmol/l; and for NPH, 10.7 mmol/l. Both formulations of insulin glargine were well tolerated, similar to NPH insulin. CONCLUSIONS: Basal insulin glargine administered once daily for 4 weeks as part of a basal-bolus multiple daily insulin regimen was safe and more effective in lowering fasting plasma glucose levels than NPH in patients with type 1 diabetes.

Review of insulin and its analogues in diabetes mellitus

“…Again, the incidence of hypoglycaemia was similar or lower among patients on HOE 901 [98][99][100]. More recently, the fi ndings of less frequent hypoglycaemic episodes and lower fasting plasma glucose levels compared with NPH were confi rmed in large, multicentre clinical trials with type I and type II diabetics in Europe and the United States [101][102][103][104]. Considering that less hypoglycaemia was consistently observed, these data suggest that the target fasting plasma glucose level can be lower for insulin glargine than for NPH [104].…”

“…Th e basal level of insulin may be maintained up to 20 hrs, but the time is clearly aff ected by the size of the injected dose. Th is insulin has a high affi nity for serum albumin, increasing its duration of action [122,123].…”

Comparação entre as insulinas regular pré-jantar e NPH no almoço como a terceira aplicação de insulina no tratamento de adolescentes com diabetes melito do tipo 1 em um Serviço Público de Saúde

“…Vários esquemas terapêuticos têm sido propostos para melhorar a reposição da insulina basal nos pacientes com DM 1 (4,6,7). Ebeling e cols.…”

“…O regime b a s a l -b o l u s (múltiplas doses) procura simular a secreção fisiológica da insulina, em resposta à alimentação, através dos análogos de insulina de ação ultra-rápida (lispro e aspart) ou da insulina de ação rápida (R) antes das refeições e a insulina basal através da NPH uma vez ao dia, à noite ao deitar ou a glargina (6)(7)(8).…”

Insulin analogues versus human insulin in type 1 diabetes: direct and indirect meta-analyses of efficacy and safety

“…Two independent reviewers evaluated the remaining articles (see Figure 1). The remaining 16 articles for long-acting insulin analogues (glargine vs. NPH, 7; detemir vs. NPH, 7; glargine vs detemir, 2) were included in our meta-analysis A. C. C. Sanches, C. J. Correr, R. Venson, P. R. Gonçalves, M. M. Garcia, M. S. Piantavini, R. Pontarolo 504 (Garg et al, 1995;Anderson Jr. et al, 1997; Ciofetta et al, 1999;Home, 2000;Raskin, Guthrie, et al, 2000;Raskin, Klaff et al, 2000;Ratner et al, 2000;Rosenstock et al, 2000; Bode, Strange, 2001;Tamas et al, 2001; Bode et al, 2002;Devries et al, 2003;Vague et al, 2003;Hermansen et al, 2004;Porcellati et al, 2004;Russell-Jones et al, 2004;Home et al, 2004; De Leeuw et al, 2005;Fulcher et al, 2005;Home et al, 2005;Pieber et al, 2005;Home et al, 2006;Pieber et al, 2007; Bartley et al, 2008;Heller et al, 2009; Bolli et al, 2009 b).When we combined all of the studies, we counted 5,733 patients who received a short-acting insulin analog (aspart, lispro or glulisine). For lispro vs. regular, there were 954 patients; aspart vs. regular, 681; glulisine vs. regular, 240; glulisine vs. lispro, 140; glulisine vs. aspart, 112; lispro vs. aspart, 696.…”