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ISRCTN
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ISRCTN50665418
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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601/PO
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Study hypothesis
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Investigate the safety and tolerability and the immunological and clinical effects of multiple doses of DiaPep277.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Latent autoimmune diabetes in adults.
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Participants - inclusion criteria
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1. Patients with a diagnosis of diabetes mellitus according to World Health Organisation (WHO) classification for more than 2 months and less than 5 years before enrolment
2. Diabetes controlled by diet, oral antidiabetics or insulin therapy
3. Positive for glutamic acid decarboxylase (GAD) autoantibodies
4. Male caucasian patients, aged 30 to 50 years, or female caucasian patients, aged 30 to 50 years, who are not pregnant and use safe contraceptive methods
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Participants - exclusion criteria
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1. Patients with secondary diabetes mellitus
2. Any previous insulin treatment before the first injection of study drug
3. History of intolerance or contraindications to oral hypoglycaemic medications
4. Clinical evidence of any severe diabetes-related complication
5. Allergy to investigational drug
6. History of severe allergy or asthma
7. Known immune deficiency from any disease, or a condition associated with an immune deficiency
8. Use of immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication which, in the opinion of the investigator, might interfere with the study
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Anticipated start date
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17/04/2001
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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41 - study completed as of Dec'06
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Interventions
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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.
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Primary outcome measure(s)
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Pancreatic beta-cell function, insulin independency or change in insulin dose, metabolic control: most parameters at every 6 months.
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Secondary outcome measure(s)
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Immune response (every 6 months), clinical safety and tolerability at each visit.
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Sources of funding
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DeveloGen AutoImmune GmbH (Germany)
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Trial website
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Publications
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Contact name
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Prof
David
Leslie
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Address
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University of London
Department of Diabetes and Immunology
St Bartholomew's Hospital
3rd Floor Dominion House
59 Bartholomew Close
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City/town
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London
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Zip/Postcode
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EC1A 7BE
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Country
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United Kingdom
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Sponsor
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DeveloGen AutoImmune GmbH (Germany)
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Address
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Max-Planck-Str. 15b
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City/town
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Erkrath
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Zip/Postcode
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40699
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Country
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Germany
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Date applied
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12/09/2005
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Last edited
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07/09/2007
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Date ISRCTN assigned
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21/10/2005
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