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A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes.
Diabetes Metab Res Rev. 2005 Nov-Dec; 21(6):545-53.DM

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 >or=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.

Authors+Show Affiliations

Newcastle Diabetes Centre and University of Newcastle upon Tyne, Newcastle upon Tyne, UK. philip.home@newcastle.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16021649

Citation

Home, P D., et al. "A Randomized Multicentre Trial of Insulin Glargine Compared With NPH Insulin in People With Type 1 Diabetes." Diabetes/metabolism Research and Reviews, vol. 21, no. 6, 2005, pp. 545-53.
Home PD, Rosskamp R, Forjanic-Klapproth J, et al. A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. Diabetes Metab Res Rev. 2005;21(6):545-53.
Home, P. D., Rosskamp, R., Forjanic-Klapproth, J., & Dressler, A. (2005). A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. Diabetes/metabolism Research and Reviews, 21(6), 545-53.
Home PD, et al. A Randomized Multicentre Trial of Insulin Glargine Compared With NPH Insulin in People With Type 1 Diabetes. Diabetes Metab Res Rev. 2005 Nov-Dec;21(6):545-53. PubMed PMID: 16021649.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. AU - Home,P D, AU - Rosskamp,R, AU - Forjanic-Klapproth,J, AU - Dressler,A, AU - ,, PY - 2005/7/16/pubmed PY - 2006/1/21/medline PY - 2005/7/16/entrez SP - 545 EP - 53 JF - Diabetes/metabolism research and reviews JO - Diabetes Metab Res Rev VL - 21 IS - 6 N2 - 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 >or=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. SN - 1520-7552 UR - https://www.unboundmedicine.com/medline/citation/16021649/A_randomized_multicentre_trial_of_insulin_glargine_compared_with_NPH_insulin_in_people_with_type_1_diabetes_ L2 - https://doi.org/10.1002/dmrr.572 DB - PRIME DP - Unbound Medicine ER -