Get access

A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes




To compare insulin glargine with NPH human insulin for basal insulin supply in adults with type 1 diabetes.


People with type 1 diabetes (n = 585), aged 17–77 years, were randomized to insulin glargine once daily at bedtime or NPH insulin either once- (at bedtime) or twice-daily (in the morning and at bedtime) according to their prior treatment regimen and followed for 28 weeks in an open-label, multicentre study. Both groups continued with pre-meal unmodified human insulin.


There was no significant difference between the two insulins in change in glycated haemoglobin from baseline to endpoint (insulin glargine 0.21 ± 0.05% (mean ± standard error), NPH insulin 0.10 ± 0.05%). At endpoint, self-monitored fasting blood glucose (FBG) had decreased similarly in each group (insulin glargine −1.17 ± 0.12 mmol/L, NPH insulin −0.89 ± 0.12 mmol/L; p = 0.07). However, people on >1 basal insulin injection per day prior to the study had a clinically relevant decrease in FBG on insulin glargine versus NPH insulin (insulin glargine −1.38 ± 0.15 mmol/L, NPH insulin −0.72 ± 0.15 mmol/L; p < 0.01). No significant differences in the number of people reporting ≥1 hypoglycaemic episode were found between the two groups, including severe and nocturnal hypoglycaemia. Insulin glargine was well tolerated, with a similar rate of local injection and systemic adverse events versus NPH insulin.


A single, bedtime, subcutaneous dose of insulin glargine provided a level of glycaemic control at least as effective as NPH insulin, without an increased risk of hypoglycaemia. Copyright © 2005 John Wiley & Sons, Ltd.

Get access to the full text of this article