Insulin-naïve, oral antihyperglycaemics – glargine versus NPH insulin

StudyOutcomeBaselineEnd of studyChange from baseline / difference between groupsp value (between groups)
HbA1c
Pan 2007 (LEAD study)HbA1c (%)glargine: 9.02 SD0.88 %
NPH insulin: 9.05 SD0.84 %
glargine: 8.03%
NPH insulin: 8.28%
glargine: −0.99%
NPH insulin: −0.77%
difference in ITT population 0.22 (95% CI: 0.02, 0.42)
p=NS for per-protocol population, p=0.0319 for ITT population
patients achieving target
HbA1c (<7.5%) (%)
glargine: 38.1%
NPH insulin: 30.3%
p=NS
patients achieving target HbA1c (<7.5%) without nocturnal hypoglycaemia (%)glargine: 22.9%
NPH insulin: 14.0%
p=0.017
patients achieving target FBG (≤ 120 mg/dL) (%)glargine: 62.3%
NPH insulin: 58.7%
p=NS
hypoglycaemia
Pan 2007 (LEAD study)number of hypoglycaemic episodesglargine: 682
NPH insulin: 1019
p<0.004
symptomatic
hypoglycaemia
glargine: 515
NPH insulin: 908
p<0.0003
severe hypoglycaemiaglargine: 5
NPH insulin: 28
p<0.03
nocturnal hypoglycaemic episodesglargine: 221
NPH insulin: 620
p<0.001
glycaemic excursions
Pan 2007 (LEAD study)eight-point blood glucose profileseight-point blood glucose profiles similar between groups at study end, except for post-dinner, where BG concentration in glargine group was significantly lower than in NPH group (236 mg/dL versus 249 mg/dL, p=0.044)
total daily dose
Pan 2007 (LEAD study)daily insulin doseglargine: 9.6
SD1.5 U
NPH insulin: 9.8
SD1.9 U
glargine: 32.1
SD17.6 U
NPH insulin: 32.8
SD18.9 U
p=NS
weight change
Pan 2007 (LEAD study)BMIglargine: 24.8
SD3.1 kg/m2
NPH insulin: 25.1
SD3.3 kg/m2
glargine: +1.40 kg/m2
NPH insulin: +1.29 kg/m2
p=NS
complication ratesnot reported
adverse events
Pan 2007 (LEAD study)treatment-emergent
adverse events that were possibly treatment-related (66 events in 45 patients)
glargine: 22 patients
NPH insulin: 23 patients
majority related to injection-site reactions (45 events in 31 patients)
p not reported
serious adverse eventsno significant difference between groups, none of events considered unusual for the demographic group studiedp=NS
HR QoLnot reported

From: 6.3 Appendix 3, Evidence tables for included studies

Cover of Type 2 Diabetes
Type 2 Diabetes: Newer Agents for Blood Glucose Control in Type 2 Diabetes.
NICE Clinical Guidelines, No. 87.
Centre for Clinical Practice at NICE (UK).
Copyright © 2009, National Institute for Health and Clinical Excellence.

All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of NICE.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.