- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05351879
Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes
A Phase I/II Open Label Pilot Study to Evaluate the Safety and Feasibility of an Additional Intralymphatic Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Linköping, Sweden, 581 85
- Kliniska Forskningsenheten (Hudmottagningen), Universitetssjukhuset Linköping
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments
Time Frame: 12 months
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12 months
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Injection site reactions
Time Frame: 3 months
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3 months
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Occurrence of AEs and SAEs
Time Frame: 12 months
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12 months
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Number of Clinically Significant Abnormal Results From Laboratory measurements (hematology, clinical chemistry) and Urine analysis.
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Stimulated C-peptide During a MMTT
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Change in HbA1c
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Change in daily exogenous insulin consumption
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Change in insulin-dose-adjusted HbA1c (IDAA1c)
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Change in time in glycemic target range 3.9 to 10 mmol/L
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Change in time in hyperglycemic range > 10 mmol/L
Time Frame: Baseline and 12 months
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Baseline and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Johnny Ludvigsson, Professor, Linkoeping University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIAGNODE-B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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