Overview
Sponsor-declared trial summary
Latent Autoimmune Diabetes in Adults (LADA)
The main objective is to test for possible differences in current diabetes status (assessed by measurements of beta cell function and metabolic control) between carriers and non-carriers of HLA-DR3DQ2, 3 years after treatment with GAD-alum in our previous GADinLADA study.
Key facts
- Sponsor
- Norwegian University Of Science And Technolology
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 5 Jun 2024 → ongoing
- Decision date (initial)
- 2024-05-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective is to test for possible differences in current diabetes status (assessed by measurements of beta cell function and metabolic control) between carriers and non-carriers of HLA-DR3DQ2, 3 years after treatment with GAD-alum in our previous GADinLADA study.
Conditions and MedDRA coding
Latent Autoimmune Diabetes in Adults (LADA)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10072399 | LADA | 10027433 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-002692-34 | A pilot study on safety, feasibility and insulin-promotion by intra-inguinal lymph node injections of glutamic acid decarboxylase (GAD) in patients with LADA type of diabetes. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Signed informed consent
- Former participant in the GADinLADA study (EudraCT 2019-002692-34)
Exclusion criteria 2
- Presence of serious disease or condition (including pregnancy)
- Participation in other clinical trials, which in the opinion of the investigator makes the patient non-eligible for the project
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD221979 · Product
- Active substance
- Glutamate Decarboxylase 2, Human, Recombinant
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRALYMPHATIC USE
- Max daily dose
- 0 µg microgram(s)
- Max total dose
- 0 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- DIAMYD MEDICAL AB
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Norwegian University Of Science And Technolology
- Sponsor organisation
- Norwegian University Of Science And Technolology
- Address
- Hoegskoleringen 1
- City
- Trondheim
- Postcode
- 7034
- Country
- Norway
Scientific contact point
- Organisation
- Norwegian University Of Science And Technolology
- Contact name
- Dept. of clinical an molecular medicine
Public contact point
- Organisation
- Norwegian University Of Science And Technolology
- Contact name
- Dept. of clinical an molecular medicine
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 6 | 1 |
| Sweden | Ongoing, recruitment ended | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2024-06-05 | 2024-06-14 | 2025-11-30 | ||
| Sweden | 2024-12-17 | 2025-01-07 | 2025-11-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2023-509021-53-00_For publication | 3 |
| Protocol (for publication) | D1_ Protocol_2023-509021-53-00_Public_Version 2_Final | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Norway | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Norway_V2 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_V4_Final_SE | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangementsV2_SE | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Norway_public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Norway_Public_Version 2 | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Sweden_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Sweden_Public_V2 | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Sweden_Public_V3 | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Sweden_Public_V4 | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Sweden_Public_V5 | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Limited Participation_Norway_Version 4_25April2025_Final_Public | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC rhGAD65 Placeholder document | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsisV1_SE 2023-509021-53-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsisV2_ENG 2023-509021-53-00 | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsisV2_NO 2023-509021-53-00 | 2 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | Norway | Acceptable 2024-05-03
|
2024-05-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-20 | Norway | Acceptable 2024-05-03
|
2024-05-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-27 | Acceptable 2024-05-03
|
2024-05-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-27 | Norway | Acceptable | 2024-06-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-06-13 | Norway | Acceptable | 2024-06-13 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-07-08 | Acceptable | 2024-07-08 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-04-25 | Norway | Acceptable | 2025-04-25 |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-15 | Norway | Acceptable 2025-07-17
|
2025-07-17 |