A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes

Diamyd Medical AB0 sites106 target enrollmentJuly 3, 2017

Overview

No summary available.

Registry

who.int

Start Date

July 3, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Informed consent given by patients and/or patient’s parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
•2\. T1D according to the ADA classification diagnosed \=6 months at the time of screening
•3\. Age: \=12 and \<25 years old
•4\. Fasting C\-peptide \=0\.12 nmol/L on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
•5\. Positive for GAD65A but \< 50 000 IU/ml
•6\. Females must agree to avoid pregnancy and have a negative urine pregnancy test.
•Patients of childbearing potential must agree to use adequate contraception, until one (1\) year after the last administration of Diamyd. Adequate contraception is as follows:
•For females of childbearing potential:
•a. oral (except low\-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
•b. combined (estrogen and progestogen containing)

•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 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 anemia or significantly abnormal hematology results at screening
•6\. A history of epilepsy, head trauma or cerebrovascular 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