Open Label trial to evaluate the tolerability of a combination therapy consisting of GAD-alum (Diamyd®), etanercept and vitamin D in children and adolescents newly diagnosed with type 1 diabetes - EDCR (Etanercept Diamyd Combination Regimen)

inköping University0 sites20 target enrollmentJune 5, 2014

Overview

No summary available.

Registry

who.int

Start Date

June 5, 2014

End Date

February 25, 2019

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

inköping University

•1\.Informed consent given by patients and parent(s)/legal guardian(s)
•2\.Type 1 diabetes according to the ADA classification, diagnosed within the previous 100 days at the time of screening
•3\.Age 8\.00 \-17\.99 years at time of screening
•4\.Fasting C\-peptide at time of screening \=0\.12 nmol/l
•5\.Positive for GADA but \< 50 000 Units
•6\.Menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test
•7\.Immunity against Varicella, either through previous infection or vaccination
•8\.Patients must follow the Swedish vaccination programme
•9\.Patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of GAD\-alum and etanercept. Adequate contraception is as follows:
•For females of childbearing potential:

•1\.Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
•2\.Continuous treatment with anti\-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 (especially hypoglycemic agents) 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 hypercalcemia
•6\.A history of anaemia or significantly abnormal haematology results at screening
•7\.A history of epilepsy, head trauma or cerebro\-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
•8\.Clinically significant history of acute reaction to vaccines or other drugs in the past
•9\.Treatment with any vaccine within 4 months prior to planned first administration of GAD\-Alum or planned treatment with vaccine up to 4 months after the last injection with GAD\-Alum, including influenza vaccine
•10\.Participation in other clinical trials with a new chemical entity within the previous 3 months