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
| ISRCTN | ISRCTN50665418 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50665418 |
| Protocol serial number | 601/PO |
| Sponsor | DeveloGen AutoImmune GmbH (Germany) |
| Funder | DeveloGen AutoImmune GmbH (Germany) |
- Submission date
- 12/09/2005
- Registration date
- 21/10/2005
- Last edited
- 07/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Leslie
Scientific
Scientific
University of London
Department of Diabetes and Immunology
St Bartholomew's Hospital
3rd Floor Dominion House
59 Bartholomew Close
London
EC1A 7BE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Investigate the safety and tolerability and the immunological and clinical effects of multiple doses of DiaPep277. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | DiaPep277 |
| Primary outcome measure(s) | Pancreatic beta-cell function, insulin independency or change in insulin dose, metabolic control: most parameters at every 6 months. |
| Key secondary outcome measure(s) | Immune response (every 6 months), clinical safety and tolerability at each visit. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 41 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/04/2001 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
- Germany
Study participating centre
University of London
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
