Status:
COMPLETED
Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes
Lead Sponsor:
Linkoeping University
Collaborating Sponsors:
Diamyd Medical AB
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The objective of the study is to evaluate the feasibility and safety of administering a 4th or 5th intralymphatic booster dose of GAD-alum (Diamyd®) to T1D patients carrying HLA DR3-DQ2, who have earl...
Detailed Description
The study is a phase I/II, single arm, open label pilot clinical trial. Eligible patients will receive one booster injection of Diamyd® administered into an inguinal lymph node. The patients will be ...
Eligibility Criteria
Inclusion
- Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
- T1D according to the ADA classification
- Carry HLA DR3-DQ2 haplotype
- Prior participation in either the DIAGNODE-1 or the DIAGNODE-2, having received four or three intralymphatic injections of Diamyd, respectively.
- Females must agree to avoid pregnancy and have a negative urine pregnancy test.
- Patients of childbearing potential must agree to use adequate contraception, until 90 days after the administration of Diamyd. Adequate contraception is as follows:
- For females of childbearing potential:
- oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
- combined (estrogen and progestogen containing)
- oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
- intrauterine device
- intrauterine hormone-releasing system (for example, progestin-releasing coil)
- bilateral tubal occlusion
- vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- male partner using condom
- abstinence from heterosexual intercourse
- For males of childbearing potential:
- condom (male)
- abstinence from heterosexual intercourse
Exclusion
- Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. 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 Vitamin D, marketed or not, or unwilling to abstain from such medication during the supplementation period
- A history of anemia or significantly abnormal hematology results at screening
- A history of epilepsy, head trauma or cerebrovascular 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, including Diamyd
- Treatment with any vaccine, including influenza or Covid19 vaccine, within 1 month prior to planned study drug dose administration or planned treatment with any vaccine up to 1 month after the injection with study drug
- Participation in clinical trials (other than DIAGNODE-1 and DIAGNODE-2) 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 s
- Ongoing diagnosed or suspected post-Covid19 syndrome
- Known HIV or hepatitis
- Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd treatment)
- Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic 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
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05351879
Start Date
May 9 2022
End Date
August 29 2023
Last Update
December 11 2023
Active Locations (1)
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1
Kliniska Forskningsenheten (Hudmottagningen), Universitetssjukhuset Linköping
Linköping, Sweden, 581 85