Drugs / GAD-Alum
GAD-Alum
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02352974 | Jan 2015 → Oct 2019 | type 1 diabetes mellitus | Johnny Ludvigsson | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05351879 | May 2022 → Aug 2023 | type 1 diabetes mellitus | Linkoeping University | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01129232 | Jan 2011 → Jan 2013 | enterovirus infectious disease, immune dysregulation, autoimmunity, and autoinflammation, type 1 diabetes mellitus | Oslo University Hospital | Terminated | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01785108 Comparator | Feb 2013 → Mar 2017 | type 1 diabetes mellitus | Johnny Ludvigsson | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Diamyd Therapeutics AB | Results Now published: Retogatein from Diamyd Medical delays the need for insulin by more than five years in the randomized, placebo-controlled diabetes prevention – Immune Tolerance Trial diamyd.com ↗
While we do not yet prevent type 1 diabetes, the published data show that retogatein delayed the need for insulin by 5.6 years in the treatment responder group. |
| 2026-09-24 | Diamyd Therapeutics AB | Results Diamyd’s retogatein delays insulin requiring Type-1 Diabetes for more than 5 years diamyd.com ↗
Long-term follow-up of the randomized, placebo-controlled DiAPREV-IT study, now in press in Diabetologia, shows that two subcutaneous injections of retogatein (GAD-alum) significantly delayed Stage 3 Type 1 Diabetes by over five years in a genetically defined subgroup of children. |
| 2026-04-10 | Diamyd Therapeutics AB | Results Diamyd Medical discontinues DIAGNODE-3 following evaluation confirming futility; initiates strategic review diamyd.com ↗
Following the previously reported interim analysis and subsequent evaluation of the interim results, including independent external statistical validation, the Company has concluded that the interim results meet the pre-specified futility criteria and do not support continuation. |
| 2026-03-29 | Diamyd Therapeutics AB | Results Diamyd Medical updates on the interim efficacy analysis of Phase 3 DIAGNODE-3 trial diamyd.com ↗
Based on the interim dataset, no treatment effect on C-peptide was observed, neither in the overall population nor in pre-specified subgroups, including the previously identified potential super responder group. |
| 2026-03-27 | Diamyd Therapeutics AB | Results Diamyd Medical reports negative interim results of Phase 3 DIAGNODE-3 trial diamyd.com ↗
The interim analysis that included 174 out of 321 study participants did not demonstrate statistical significance on the primary endpoint at this timepoint. |
All press releases naming this drug 43 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GAD-alum | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05351879 ↗ |
| Known as | Diamyd | “GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals” NCT02352974 ↗ |
| Known as | glutamic acid decarboxylase (GAD)-alum | “AIM: Double-blind placebo-controlled intervention using glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen in recent onset Type I diabetes (T1D).” PMID 32802401 ↗ Jun 2020 |
| Modality | Vaccine | “GAD vaccination” NCT01129232 ↗ |
| Route | Subcutaneous | “injected sc” NCT01129232 ↗ |