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

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Abstract
Background To compare insulin glargine with NPH human insulin for basal insulin supply in adults with type 1 diabetes. Methods 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. Results 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. Conclusions 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.

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