Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
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®
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: GAD-Alum (DIamyd) 40 μg/mL and Vitamin D 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. |
Biological: GAD-alum (Diamyd) 40 μg/mL
Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) adsorbed to Alhydrogel at a concentration of 40 μg/mL and is given as a sterile solution for intralymphatic injection
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Outcome Measures
Primary Outcome Measures
- 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
- 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]
- 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 time in hyperglycemic range > 10 mmol/L [Baseline and 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
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T1D according to the ADA classification
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Carry HLA DR3-DQ2 haplotype
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Prior participation in either the DIAGNODE-1 or the DIAGNODE-2, having received four or three intralymphatic injections of Diamyd, respectively.
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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:
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oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
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combined (estrogen and progestogen containing)
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oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
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intrauterine device
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intrauterine hormone-releasing system (for example, progestin-releasing coil)
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bilateral tubal occlusion
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vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
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male partner using condom
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abstinence from heterosexual intercourse
For males of childbearing potential:
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condom (male)
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abstinence from heterosexual intercourse
Exclusion Criteria:
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Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
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Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
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Treatment with any oral or injected anti-diabetic medications other than insulin
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Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the supplementation period
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A history of anemia or significantly abnormal hematology results at screening
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A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
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Clinically significant history of acute reaction to vaccines or other drugs in the past, including Diamyd
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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
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Participation in clinical trials (other than DIAGNODE-1 and DIAGNODE-2) with a new chemical entity within the previous 3 months
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Inability or unwillingness to comply with the provisions of this protocol
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A history of alcohol or drug abuse
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A significant illness other than diabetes within 2 weeks prior to first dosing s
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Ongoing diagnosed or suspected post-Covid19 syndrome
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Known HIV or hepatitis
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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)
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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
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Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Kliniska Forskningsenheten (Hudmottagningen), Universitetssjukhuset Linköping | Linköping | Sweden | 581 85 |
Sponsors and Collaborators
- Linkoeping University
- Diamyd Medical AB
Investigators
- Principal Investigator: Johnny Ludvigsson, Professor, Linkoeping University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIAGNODE-B