Clinical trial • Phase IV • Immunology

Glutamate decarboxylase 2, human, recombinant for Latent autoimmune diabetes in adults (LADA)

Phase IV trial of Glutamate decarboxylase 2, human, recombinant for Latent autoimmune diabetes in adults (LADA). 14 participants. CTIS 2019-002692-34.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Latent autoimmune diabetes in adults (LADA)
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
09-02-2024
First CTIS Authorization Date
03-05-2024

Trial design

Phase IV trial across 2 sites in Norway, Sweden.

Biomarker Stratified
True, HLA-DR3DQ2 carrier status (carriers vs non-carriers)
Target Sample Size
14

Eligibility

Recruits 14 No vulnerable populations selected. Participants are adults; signed informed consent is required. Subject information and informed consent forms for adults are provided for Norway and Sweden (multiple versions). No paediatric assent procedures described..

Pregnancy Exclusion
Presence of serious disease or condition (including pregnancy)
Vulnerable Population
No vulnerable populations selected. Participants are adults; signed informed consent is required. Subject information and informed consent forms for adults are provided for Norway and Sweden (multiple versions). No paediatric assent procedures described.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent\n- Former participant in the GADinLADA study (EudraCT 2019-002692-34)"}

Exclusion criteria

  • {"criterion_text":"- Presence of serious disease or condition (including pregnancy)\n- Participation in other clinical trials, which in the opinion of the investigator makes the patient non-eligible for the project"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in diabetes status variables (beta cell insulin secretion capacity and metabolic control) 3 years after treatment with GAD-alum (IMP) in the GADinLADA study, compared to baseline and the end of study (i.e., 12 months after baseline) in GADinLADA.","definition_or_measurement_approach":"Assessed by measurements of beta cell function (insulin secretion capacity) and metabolic control, comparing values at ~3 years after prior treatment with GAD-alum to baseline and to end of study (12 months after baseline) in the prior GADinLADA study."}

Recruitment

Planned Sample Size
14
Recruitment Window Months
11
Consent Approach
Signed informed consent is required from adult participants. Subject information and informed consent forms (ICF) for adults are provided for Norway and Sweden (multiple versions available). No paediatric assent described.

Geography

Total Number Of Sites
2
Total Number Of Participants
14

Norway

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
17-07-2025
Processing Time Days
447
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Norwegian University Of Science And Technolology
Department Name
Department of clinical and molecular medicine
Contact Person Name
Chandima Balasuriya
Number Of Participants
6

Sweden

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
451
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Karolinska Institutet
Department Name
Department of Molecular Medicine and Surgery
Contact Person Name
Anneli Björklund
Contact Person Email
anneli.bjorklund@ki.se
Number Of Participants
8

Sponsor

Primary sponsor

Full Name
Norwegian University Of Science And Technolology
Organisation Type
Educational Institution
Country Of Registered Address
Norway

Investigational products

Investigational Product Name
Diamyd
Active Substance
Glutamate decarboxylase 2, human, recombinant
Modality
Peptide/protein/enzyme
Routes Of Administration
Intralymphatic use
Route
Intralymphatic use
Authorisation Status
Authorised

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