Glibenclamide

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Burke and Hartog, 198427720 adult patients with type 1 diabetes
Mean age 28 (range 20–36 years), duration of diabetes 0.75 to 14 years, 6 female, 14 male
Bristol, UK
Trial length 3 months
Inclusion criteria: no ketoacidosis in the previous 6 months
C-peptide secretors (0.07 nmol/l) and Cpeptide non-secretor individuals analysed separately
Treatment
  1. insulin and glibenclamide
    15 mg daily
  2. insulin and placebo
Diabetes control – patient collecting own capillary blood glucose samples, capillary blood spot filter paper method
Mean daily blood glucose
Mean index of blood glucose variation
HbA1 at end of period
Fasting blood glucose before GTT
Oral 50 g glucose tolerance test (OGTT), area blood glucose during OGTT, plasma C-peptide area during OGTT, fasting plasma glucose C-peptide ratio
In the C-peptide secretors, there were differences in the glibenclamide compared with the placebo group: mean daily blood glucose (7.4 ± 1.5 vs. 8.4 ± 1.7 mmol/l, p = 0.02), mean index of blood glucose variation (140 ± 132 vs. 202 ± 180, p = 0.05), HbA1 (7.5 ± 0.9% vs. 8.1 ± 0.5%, p = 0.05)
Plasma C-peptide area during OGTT and fasting plasma glucose C-peptide ratio both significantly improved whilst on glibenclamide and insulin treatment. (47.5 ± 28.4 vs. 32.3 ± 16.0 nmol min, p = 0.01 and 49 ± 33 vs. 72 ± 47 mmol/nmol p = 0.008, respectively)
No significant difference in the fasting blood glucose before GTT and the area blood glucose during OGTT
In the C-peptide non-secretors, there was no significant difference in any of the outcomes: HbA1 (8.6 ± 0.3% to 8.9 ± 1.5%, p > 0.05), mean daily blood glucose (8.9 ± 2.3 to 9.5 ± 2.8 mmol/l, p > 0.05), mean index of blood glucose variation (352 ± 264 to 309 ± 205, p > 0.05)
No description of how randomisation took place
Sponsored by Hoechst (UK) pharmaceuticals
RCT, double blind crossover trial
3 months 1 therapy, 1 month washout, 3 months other therapy
Ib
Stocks et al, 19882746 adult patients with type 1 diabetes
Australia
3 times a day for 1 month:
  1. oral weight adjusted glibenclamide 10 mg
At end of treatment period 24-hour glucose profile, free insulin level every 15 min, both to give area under curve
Glycated haemoglobin level
No significant difference was observed between the net effect of the placebo or glibenclamide treatment on the glycated haemoglobin level, (0.4 ± 0.4% vs. −0.2 ± 0.3%, p > 0.05), the daily insulin requirement (3.0 ± 5.0 vs. −1.0 ± 2.5 units/day, p > 0.05), the areas under the glucose curve (−12.3 ± 12.2 vs. −13.2 ± 8.2, p > 0.05), and free insulin curve (−35.9 ± 51.1 vs. 47.5 ± 107.1, p > 0.05)No description of how randomisation took placeRCT double blind placebo-controlled crossover study
4 weeks wash-out period
Ib
Kabadi et al, 199527510 men with type 1 diabetes
Aged 31–66 years
USA
3-phase trial, each lasting 3 months. First stage was a run-in stabilisation, and then patients were randomised to additional treatments, after 3 months patients were crossed over to the other treatment
  1. glibenclamide 5 mg 2 tablets twice daily
  1. HbA1 and blood glucose levels monthly
  2. Fasting serum cholesterol and triglycerides
  3. Number of hypoglycaemic events (< 2.8 mmol/l)
  1. No significant difference in HbA1 (glibenclamide 6.5 ± 0.2 vs. placebo, 9.9 ± 0.2%)
    The 24-hour average capillary blood glucose level as well as the difference between the mean postprandial and the preprandial blood glucose concentrations were significantly lower during the treatment with glibenclamide treatment (all values are given as; mean ± SEM):
    24-hour average capillary blood glucose level:
    glibenclamide 7.4 ± 0.4 vs. placebo 8.7 ± 0.5 mmol/l, p < 0.05
    Difference between the mean postprandial blood glucose concentrations: glibenclamide 8.7 ± 0.4 vs. placebo 10.8 ± 0.5 mmol/l, p < 0.01
    Difference between the mean preprandial blood glucose concentrations: glibenclamide 6.6 ± 0.4 vs. placebo 8.2 ± 0.5 mmol/l, p < 0.05
    Fasting plasma glucose was not significantly different between different treatment groups: glibenclamide 6.3 ± 0.5 vs. placebo 7.0 ± 0.6 mmol/l)
  2. Fasting serum cholesterol and triglycerides were not significantly different between the treatment groups:
    Cholesterol: glibenclamide 4.8 ± 0.3 vs.
    placebo 5.5 ± 0.3 mmol/l
    Triglycerides: placebo 1.3 ± 0.2 vs.
    glibenclamide 1.3 ± 0.2 mmol/l
  3. Hypoglycaemic episodes were significantly reduced in the glibenclamide treatment group: glibenclamide 1.8 ± 3 vs. placebo 3.8 ± 0.8 mmol/l, p < 0.01
No description of how randomisation took placeRCT crossoverIb
Bieger et al, 198427621 patients with type 1 diabetes
Aged 41.8 ± 11.1 years
Germany
Run-in period for 2 weeks following normal regimen with the addition of treatment for 6 weeks
  1. glibenclamide 10 mg
  1. Self-monitored blood glucose
  1. No significant difference in HbA1c between the treatment groups: glibenclamide 10.4 ± 2.1% vs. placebo 12.0 ± 1.5%
  2. No significant difference in mean blood glucose levels between the treatment groups
No description of how randomisation took placeRCTIb

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.

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