Latent autoimmune diabetes in adults. Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
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 th
Sponsors
DeveloGen AutoImmune GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pancreatic beta-cell function, insulin independency or change in insulin dose, metabolic control: most parameters at every 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response (every 6 months), clinical safety and tolerability at each visit. | — |
Countries
Germany
Outcome results
None listed