RCT with different outcomes to those in meta-analysis

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Home and Lindholm, 199817190 adult patients with type 1 diabetes
Aged 18–60 years
11 sites in the UK
4-week run-in period: patients were treated with human unmodified insulin (soluble insulin) just before meal times, and bedtime isophane insulin. Patients were then randomised to a treatment A or B for 4 weeks and then crossed over to the other treatment for a final 4 weeks
  1. soluble insulin
Insulin dosage
Preprandial blood glucose profiles
24-hour plasma and serum insulin profile were performed
Serum fructosamine concentration
Hypoglycaemia (classified as minor if self dealt with or major if required help from a third party)
Adverse events
No significant difference in the insulin dosage. The post-breakfast serum insulin concentration was lower in the aspart group (aspart 44 ± 20 vs. unmodified 60 ± 37 munits/l, p < 0.05), it was also lower in the early part of the night (aspart 26 ± 16 vs. unmodified 32 ± 27 munits/l at 01:00 p < 0.05)
Overall 24-hour glucose control defined by plasma glucose leaving 4.0–7.0 mmol/l range. Significantly improved in aspart treatment (aspart 5260 ± 3361 vs. unmodified 4713 ± 4310 mmol/l/min p < 0.01). When split by > 7.0 and < 4.0, the decrease in deviations from plasma glucose level was significant in the > 7.0 for the aspart treatment but not for the < 4.0 mmol/l plasma glucose level
8-point self measured blood glucose level showed no statistical change in glucose concentrations apart from the lunch and dinner postprandial concentrations, which were lower in the aspart treatment, (after lunch: aspart 6.4 ± 3.0 vs. unmodified 8.1 ± 3.7 mmol/l, p < 0.05; after dinner: aspart 7.2 ± 3.1 vs. unmodified 8.8 ± 3.5 mmol/l, p < 0.05)
No difference in blood glucose control as assessed by serum fructosamine (aspart 3.76 ± 0.53 vs. unmodified 3.82 ± 0.56 mmol/l, NS)
There was no significant difference in the number of hypoglycaemic events (aspart 567 vs. unmodified 615). The were significantly fewer major hypoglycaemic event in the aspart treatment (20 events in 24 patients vs. 44 events in 24 patients, p < 0.002)
There were a higher number of other treatment-emergent adverse events (excluding hypoglycaemia) in the aspart group (81 vs. 66, NS). 5 adverse events in the aspart and 8 in the unmodified treatment group were judged by the clinician as possibly being related to the insulin aspart
No description of how randomisation took place
Supported by Novo Nordisk
RCT crossover multicentre double blindIb

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, 1988, no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

The rights of National Collaborating Centre for Women’s and Children’s Health to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.