Other immunotherapies

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Secchi et al, 19906525 patients with type 1 diabetes within 8 weeks of diabetes onset
Aged 24 ± 6 years
Italy
Prednisone 15 mg/day (n = 10)
versus
indomethacin 100 mg/day) (n=5)
versus
placebo (n = 10)
Trial length: 8 months
  1. Partial remission
  2. Adverse effects
  1. 6/9 vs. 1/4 vs. 2/10
  2. Prednisone: facies lunaris and epigastralgia
No description of randomisationRCT
multicentre
Ib
Secchi et al, 19866610 patients with type 1 diabetes
Italy
Theophylline 800 mg/day (n=5)
versus
placebo (n = 5)
Trial length: 1 month
Partial remission4/5 vs. 2/4No description of randomisationRCTIb
Giordano et al, 19906716 patients with type 1 diabetes within two weeks of initiation of insulin therapy
Aged 12–31 years
Italy
Thymopentin 1 mg/kg for 7 days and twice per week for up to 3 months (n = 16)
versus
control (n = 32)
  1. Remission
  1. At 6 months: 7/16 vs. 3/30
    At 1 year: 9/16 vs. 2/30
    p range ≤ 0.05–0.001
  2. At 1 month: 8.8 ± 0.4% vs. 8.7 ± 0.3%
    At 6 months: 6.2 ± 0.2% vs. 6.5 ± 0.1%
    At 1 year: 6.4 ± 0.4% vs. 7.5 ± 0.5%
    No statistical difference
Method of randomisation through the unbalanced zanolomization method
2 patients in control group lost to follow-up
RCTIb
Koivisto et al, 19846843 patients with type 1 diabetes
Aged 15–25 years
Mean age 20 ± 1 years for intervention group and 21 ± 1 years for control group)
Finland
Interferon 3×106iu and 2.3mg protein in phosphate-buffered saline for 2 weeks (n = 20)
versus
2.3 mg human albumin in 0.5 ml phosphate-buffered saline for 2 weeks (n = 23)
Trial length: intervention for 2 weeks, follow-up for 30 months
  1. Remission
  1. At 1 month: 8.9 ± 0.3% vs. 9.1 ± 0.4%
    At 6 months: 8.1 ± 0.5% vs. 7.9 ± 0.5%
    At 12 months: 8.6 ± 0.6% vs. 9.7 ± 0.7%
    At 30–36 months (n = 9, n = 9): 9.8 ± 0.6% vs. 9.5 ± 0.7%
    No statistical difference
  2. At 1 year: 6/20 vs. 12/23
No description of randomisationRCTIb
Buckingham and Sandborg, 20006910 children with type 1 diabetes within 11 days of diagnosis
Aged 7–12 years
USA
Methotrexate 5 mg/m2/week (n=5)
versus
control (n = 5)
RemissionAt 18 months: 1/5 vs. 3/5
Adverse events during methotrexate treatment: mouth sores (n = 1), upper respiratory infection (n = 1), gastroenteritis (n = 1), vermicelli (n = 1), transient increase in liver function (n = 1)
Randomisation through random number table, by administrative assistant not involved in patient careRCTIb
Cook et al, 19897049 children with type 1 diabetes within 20 days of diagnosis
Mean age 11.7 for azathioprine, 9.9 years for placebo
Australia
Azathioprine 2 mg/kg/day (n = 24)
versus
placebo (n = 25)
  1. Remission
  1. At 6 months: 7/24 vs. 10/25
    At 1 year: 4/24 vs. 4/25
    No statistical difference
  2. At 6 months: 7.2 ± 0.4% vs. 6.6 ± 0.2%
    At 12 months: 7.7 ± 0.3% vs. 7.1 ± 0.3%
    No statistical difference
    Adverse effects: skin lesions
Randomisation unknown to participating doctors and patientsRCTIb

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.