Trial to evaluate the safety and diabetes status in patients with recent-onset Type 1 diabetes by giving GAD-antigen (Diamyd®) therapy into lymph NODEs in combination with an oral Vitamin D regime

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 20.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-001417-79-SE
• Lead Sponsor: inköping University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-02
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.Informed consent given by patients and/or patient’s parent (s) or legal acceptable representative(s) (guardian(s)) according to national regulations
2.Type 1 diabetes according to the ADA classification with < 6 months diabetes duration
3.Age 12.00-29.99 years at diagnosis of Type 1 diabetes
4.Fasting C-peptide =0.12 nmol/L
5.Pos GADA but < 50 000 random units
6.Females must agree to avoid pregnancy and have a negative urine pregnancy test
7.Patients of childbearing potential must agree to using adequate contraception, until 1 year after the last administration of GAD-Alum. 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.intrauterine device
c.intrauterine system (for example, progestin-releasing coil)
d.vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)

For males of childbearing potential:
e.condom (male)

Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
2.Continuous treatment with any 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 anaemia or significantly abnormal haematology results at screening
6.A history of epilepsy, head trauma or cerebro-vascular 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
11.A history of alcohol or drug abuse
12.A significant illness other than diabetes within 2 weeks prior to first dosing
13.Known human immunodeficiency virus (HIV) or hepatitis
14.Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the GAD-Alum treatment)
15.Males or females not willing to use adequate contraception until 1 year after the last GAD-Alum treatment
16.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
17.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