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Prof David Leslie


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Be Part of Research - Trial Details - Randomised, double-blind, placebo-controlled, multi-centre, parallel group study to investigate the safety and tolerability as well as the immunological and clinical effects of multiple subcutaneous doses of DiaPep277 in latent autoimmune diabetes in adults (LADA) patients
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Randomised, double-blind, placebo-controlled, multi-centre, parallel group study to investigate the safety and tolerability as well as the immunological and clinical effects of multiple subcutaneous doses of DiaPep277 in latent autoimmune diabetes in adults (LADA) patients

Not Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Latent autoimmune diabetes in adults.

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Not provided at time of registration

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

17 Apr 2001 31 Dec 2005

Interventional

Intervention Type : Drug
Intervention Description : Treatment with subcutaneous injections of DiaPep277 or placebo in three different treatment groups with different schedules for a period of approximately 18-20 months. Follow up until 2 years after the first administration of study drug.

Group A: Administration of 1 mg DiaPep277 or placebo at the start of the study and 1 month, 6 months, 12 months and 18 months later. In total five administrations.Group B: Administration of 1 mg DiaPep277 or placebo at the start of the study and 2 weeks, 4 weeks, 6 weeks and 8 weeks later. Further administrations in intervals of approximately 3 months. In total 10 administrations.Group C: Administration of 0.2 mg DiaPep277 or placebo at the start of the study and 2 weeks, 4 weeks, 6 weeks and 8 weeks later. This course is repeated 6 months, 12 months and 18 months after the first administration. In total 20 administrations.




You can take part if:



You may not be able to take part if:


1. Patients with secondary diabetes mellitus2. Any previous insulin treatment before the first injection of study drug3. History of intolerance or contraindications to oral hypoglycaemic medications4. Clinical evidence of any severe diabetes-related complication5. Allergy to investigational drug6. History of severe allergy or asthma7. Known immune deficiency from any disease, or a condition associated with an immune deficiency8. Use of immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication which, in the opinion of the investigator, might interfere with the study


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of London
    London
    EC1A 7BE

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Prof David Leslie



The study is sponsored by DeveloGen AutoImmune GmbH (Germany) and funded by DeveloGen AutoImmune GmbH (Germany).




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Read full details for Trial ID: ISRCTN50665418
Last updated 07 September 2007

This page is to help you find out about a research study and if you may be able to take part

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