Pilot Trial to preserve residual insulin secretion in children and adolescents with recent onset Type 1 diabetes by using GAD-antigen (Diamyd) therapy in combination with Vitamin D and Ibuprofen .

Phase 1

• Conditions: Type 1 diabetes in children and adolescents; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-003251-11-SE
• Lead Sponsor: inköping university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-25
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Informed consent given by patients and guardians/parents
•Type 1 diabetes according to the ADA classification with < 4 months diabetes duration
•Age 10.00 -17.99 years at Diagnosis of Type 1 diabetes
•Fasting C-peptide >0.12 nmol/ml
•Pos GADA but < 50 000 random units

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified