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

Lookup NU author(s): Emeritus Professor Philip Home

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Abstract

Background: To compare insulin glargine with NPH human insulin for basal in 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.

Publication metadata

Author(s): Home PD, Rosskamp R, Forjanic-Klapproth J, Dressler A, Bartusch-Marrain P, Egger T, Francesconi M, Irsigler K, Kazerovsky-Bielesc G, Pieber T, Prager R, Weitgasser R, Saudek F, Laursen HB, Christensen C, Hermansen K, Juhl H, Soelling K, Bergkulla S, Haapamaki H, Harno K, Salmela P, Voutilainen E, Bringer J, Charbonnel B, Charpentier G, Durlach V, Gouet D, Grenier JL, Ozenne G, Penfornis A, Pinget M, Rodier M, Valensi P, Vexiau P, Warnet A, Austenat E, Beyer J, Dreyer M, Haslbeck M, Ittner JR, Landgraf R, Laube H, Lembcke HJ, Liebl A, Lotz N, Matthei S, Palitzsch KD, Paschke R, Usadel KH, Raptis S, de Heide LJM, van Hoogenhuijze J, Lutterman JA, Spooren PFMJ, Dyrbekk D, Vaaler S, Berne C, Eriksson J, Lins PE, Diem P, Gaillard R, Gray RS, Thow JC, Reckless J, Sampson M, Tindall H

Publication type: Article

Publication status: Published

Journal: Diabetes/Metabolism Research and Reviews

Year: 2005

Volume: 21

Issue: 6

Pages: 545-553

Print publication date: 01/11/2005

ISSN (print): 1520-7552

ISSN (electronic): 1520-7560

Publisher: Wiley-Blackwell

URL: http://dx.doi.org/10.1002/dmrr.572

DOI: 10.1002/dmrr.572

PubMed id: 16021649

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