Type 1 diabetes MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Linköping University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent given by patients and/or patient’s parent (s) or legal acceptable representative(s) (guardian(s)) according to national regulations 2. Type 1 diabetes according to the ADA classification with =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted) 2. Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted) 3. Treatment with any oral or injected anti-diabetic medications other than insulin 4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial 5. A history of anaemia or significantly abnormal haematology results at screening 6. A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles 7. Clinically significant history of acute reaction to vaccines or other drugs in the past 8. Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug. 9. Participation in other clinical trials with a new chemical entity within the previous 3 months 10. Inability or unwillingness to comply with the provisions of this protocol 11. A history of alcohol or drug abuse 12. A significant illness other than diabetes within 2 weeks prior to first dosing 13. Known human immunodeficiency virus (HIV) or hepatitis 14. Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the GAD-Alum treatment) 15. Males or females not willing to use adequate contraception until 1 year after the last GAD-Alum treatment 16. Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study 17. Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the safety of giving Diamyd directly into lymph glands in combination with an oral vitamin D regimen • Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion. ;Secondary Objective: Not applicable;Primary end point(s): Primary endpoints: To evaluate the safety of giving Diamyd directly into lymph glands in combination with an oral vitamin D regimen at Month 6 (main study period) and Month 15 and 30 (extension study period). Variables to evaluate safety: • Reactions of the injection site • Occurrence of adverse events (AEs) • Laboratory measurements (biochemistry and haematology), including Calcium and Vitamin D in serum • Urinalysis (microalbuminuria, creatinine) • Physical examinations, including neurological assessments • GAD65AB titer (GADA) ;Timepoint(s) of evaluation of this end point: Month 6, 15 and 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: To evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion from baseline to Month 6 (main study period) and subsequent visits during the extension study period. Variables to evaluate the influence on the immune system • Inflammatory markers, especially TNF-alfa, IL-1 beta, IL-2, IL-17 • Th2-deviation of cell-mediated immune response seen e.g. as increased ratio of IL-5,10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta and IL-17 • Increase of T-regulatory cells Variables to evaluate the effect of endogenous insulin secretion: • C-peptide (90 minute value and AUCmean 0-120 min) during an MMTT) • Fasting C-peptide • Hemoglobin A1c (HbA1c) • Exogenous insulin dose per kg body weight and 24 hours ;Timepoint(s) of evaluation of this end point: Month 6, 15 and 30 | — |
Countries
Sweden
Contacts
Public ContactJohnny Ludvigsson
Linköping University
Outcome results
None listed