Type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Product Name: Diamyd
Product Code: rhGAD65 formulated in alum (GAD-alum)
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration
Sponsors
Diamyd Therapeutics AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients of any race between 10 and 18 years of age. 2. Type 1 diabetes mellitus diagnosed within the previous 18 months and the onset at least 14 days prior to Primary injection 3. C-peptide level above 0.1 nmol/l. 4. Presence of GAD65 antibodies 5. Written informed consent both from the patient and the guardian where applicable. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Secondary diabetes mellitus. 2.Treatment with immunosuppressant(s). 3. A history of anaemia or significantly abnormal haematology results at screening. 4. A history of epilepsy, head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles. 5. Clinically significant history of acute reaction to drugs in the past. 6. Treatment with any vaccine within one month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd. 7. Participation in other clinical trials with a new chemical entity within the previous 3 months. 8. Inability or unwillingness to comply with the provisions of this protocol. 9. A history of alcohol or drug abuse. 10. A significant illness other than diabetes within 2 weeks prior to first dosing. 11. HIV or hepatitis. 12. Females pregnant at the time of injection or plans for pregnancy during the next 13 months ( one year after 2 nd administration). 13. MODY- Maturity Onset Diabetes in the young, known or likely 14. Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is intended to evaluate the effect of 20 µg Diamyd on the preservation of pancreatic beta cell function as defined by an increase in fasting C-peptide. In addition, the proposed study will provide further data to evaluate the safety of Diamyd treatment. The primary objective is to evaluate the efficacy of 20 µg Diamyd, versus placebo. ;Secondary Objective: The secondary objective is to evaluate the safety of 20 µg Diamyd treatment. ;Primary end point(s): The primary efficacy endpoint is the change in fasting concentration of C-peptide from baseline to 15 months after the first injection. The secondary efficacy endpoints are changes from baseline to various time-points for the following variables: The concentration of HbA1c Fasting concentration of C-peptide Concentration of C-peptide after challenge with Sustacal | — |
Countries
Sweden
Outcome results
None listed