A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes
Article first published online: 15 JUL 2005
Copyright © 2005 John Wiley & Sons, Ltd.
Diabetes/Metabolism Research and Reviews
Volume 21, Issue 6, pages 545–553, November/December 2005
How to Cite
Home, P. D., Rosskamp, R., Forjanic-Klapproth, J. and Dressler, A. (2005), A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. Diabetes Metab. Res. Rev., 21: 545–553. doi: 10.1002/dmrr.572
- Issue published online: 20 OCT 2005
- Article first published online: 15 JUL 2005
- Manuscript Accepted: 16 MAY 2005
- Manuscript Received: 12 AUG 2004
- Aventis Pharma
- type 1 diabetes;
- basal insulin;
- insulin glargine;
- NPH insulin;
- blood glucose control;
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.