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
- Conditions
- atent autoimmune diabetes in adults.Nutritional, Metabolic, EndocrineDiabetes
- Registration Number
- ISRCTN50665418
- Lead Sponsor
- DeveloGen AutoImmune GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 41
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pancreatic beta-cell function, insulin independency or change in insulin dose, metabolic control: most parameters at every 6 months.
- Secondary Outcome Measures
Name Time Method Immune response (every 6 months), clinical safety and tolerability at each visit.