Type 1 diabetes in children and adolescents
Conditions
Interventions
Product Name: Diamyd®
Product Code: rhGAD65 formulated with alum (GAD-alum)
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administ
Sponsors
Linköping university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent given by patients and guardians/parents • Type 1 diabetes according to the ADA classification with 0.12 nmol/ml • Pos GADA but =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted) • Continuous treatment with any inflammatory drug ( sporadic treatment eg because of headache or in connection with fever a few days will be accepted) • Treatment with any oral or injected anti-diabetic medications other than insulin • Treatment with any vitamins, marketed or not, or unwilling to abstain from such medication during the trial. • A history of anaemia or significantly abnormal haematology results at screening • A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles • Clinically significant history of acute reaction to vaccines or other drugs in the past • Treatment with any vaccine within 4 months prior to planned first study drug dose or planned treatment with vaccine up to 4 months after the last injection with study drug, including influenza vaccine • Participation in other clinical trials with a new chemical entity within the previous 3 months • Inability or unwillingness to comply with the provisions of this protocol • A history of alcohol or drug abuse • A significant illness other than diabetes within 2 weeks prior to first dosing • Known human immunodeficiency virus (HIV) or hepatitis • Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the GAD-alum treatment) • Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last GAD-alum treatment • 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. • 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 and influence of treatment with GAD-Alum (Diamyd) plus Vitamin D plus Ibuprofen on preservation of residual insulin secretion in recently-diagnosed Type 1 diabetes. • Evaluate how the abovementioned treatments influencers the immune system of the patients and interact with any viral infections. • Evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system and on preservation of residual insulin secretion in recently-diagnosed Type 1 diabetes ;Secondary Objective: Not applicable;Primary end point(s): • Th2-deviation of cellmediated immune response seen as increased ratio of IL-5,10,13 in comparison with IFNgamma, TNFalfa, and IL-1beta, IL17, and increase of T-regulatory cells. At baseline and subsequent visits. • Inflammatory markers such as IL-1,IL-2, IL-1beta, IL-17 • Change in C-peptide (90 minute value and AUCmean 0-120 min) during an MMTT from baseline to month 6, 15 resp to month 30. • Fasting C-peptide, change between baseline and month 6, 15 resp 30. • Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at baseline and month 6, 15 resp 30. • Hemoglobin A1c (HbA1c), change between baseline and subsequent visits • Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits The safety assessment includes occurrence of adverse events (AEs), laboratory measurements, brief physical examination including neurological assessments ;Timepoint(s) of evaluation of this end point: After completion of the first part of the Intervention study period , the treatment code will be revealed already after 6 months to the statistician and the sponsor, for statistical analysis of the efficacy variables and safety data. (The results will be used for design of the main DIABGAD trial.) Both patients and the physicians treating the patients will be kept blinded for individual treatment code for the entire s | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): This is a pilot trial, and we do not separate primary and seconday endpoints. Please see above.;Timepoint(s) of evaluation of this end point: After completion of the first part of the Intervention study period , the treatment code will be revealed already after 6 months to the statistician and the sponsor, for statistical analysis of the efficacy variables and safety data. (The results will be used for design of the main DIABGAD trial.) Both patients and the physicians treating the patients will be kept blinded for individual treatment code for the entire study period (30 months). | — |
Countries
Sweden
Contacts
Public ContactJohnny Ludvigsson
Linköping university
Outcome results
None listed