Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2005
Date assigned
21/10/2005
Last edited
07/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Leslie

ORCID ID

Contact details

University of London
Department of Diabetes and Immunology
St Bartholomew's Hospital
3rd Floor Dominion House
59 Bartholomew Close
London
EC1A 7BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

601/PO

Study information

Scientific title

Acronym

Study hypothesis

Investigate the safety and tolerability and the immunological and clinical effects of multiple doses of DiaPep277.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Latent autoimmune diabetes in adults.

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

DiaPep277

Primary outcome measures

Pancreatic beta-cell function, insulin independency or change in insulin dose, metabolic control: most parameters at every 6 months.

Secondary outcome measures

Immune response (every 6 months), clinical safety and tolerability at each visit.

Overall trial start date

17/04/2001

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

41 - study completed as of Dec'06

Participant exclusion criteria

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

Recruitment start date

17/04/2001

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Germany

Trial participating centre

University of London
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

DeveloGen AutoImmune GmbH (Germany)

Sponsor details

Max-Planck-Str. 15b
Erkrath
40699
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

DeveloGen AutoImmune GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes