Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Biological: GAD-alum (Diamyd) 40 μg/mL
- Registration Number
- NCT05351879
- Lead Sponsor
- Linkoeping University
- 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 earlier been treated with three or four intralymphatic doses of GAD-alum (Diamyd®) respectively.
- 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 assessed for eligibility at the screening visit (Visit 1). Patients with a Vitamin D level \<100 nmol/L (40 ng/mL) at screening will receive oral Vitamin D supplementation (2000 IU daily) for 60 days, starting 30 days prior to the injection. On Visit 2 (Day 0), patients eligible for the study will receive one intralymphatic injection of 4µg Diamyd®
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GAD-Alum (DIamyd) 40 μg/mL and Vitamin D GAD-alum (Diamyd) 40 μg/mL Patients with a Vitamin D level \<100 nmol/L (40 ng/mL) at screening will receive oral Vitamin D supplementation (2000 IU daily) for 60 days, starting 30 days prior to the injection. On Visit 2 (Day 0), patients eligible for the study will receive one intralymphatic injection of 4µg Diamyd.
- Primary Outcome Measures
Name Time Method Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments 12 months Injection site reactions 3 months Occurrence of AEs and SAEs 12 months Number of Clinically Significant Abnormal Results From Laboratory measurements (hematology, clinical chemistry) and Urine analysis. 12 months
- Secondary Outcome Measures
Name Time Method Change in time in hyperglycemic range > 10 mmol/L Baseline and 12 months Change in insulin-dose-adjusted HbA1c (IDAA1c) Baseline and 12 months Change in time in glycemic target range 3.9 to 10 mmol/L Baseline and 12 months Change in Stimulated C-peptide During a MMTT Baseline and 12 months Change in HbA1c Baseline and 12 months Change in daily exogenous insulin consumption Baseline and 12 months
Trial Locations
- Locations (1)
Kliniska Forskningsenheten (Hudmottagningen), Universitetssjukhuset Linköping
🇸🇪Linköping, Sweden