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NCT05018585 · ClinicalTrials.gov record · last posted 2026-08-26

A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes

Study acronym: DIAGNODE-3
StatusTerminated
PhasePhase 3
Started2022-05-19
View on ClinicalTrials.gov ↗
Why the trial stopped
Stopped for futility.
from the ClinicalTrials.gov record
The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

Protocol amendment history 4 changes detected by DataLookout

2026-08-27
Trial terminated
2026-08-27
Trial terminated: Stopped for futility.
2026-08-27
Primary completion moved earlier: 2027-12 → 2026-06-24
2026-08-27
Completion moved earlier: 2027-12 → 2026-06-24
Trial Details
NCT Number NCT05018585
Lead Sponsor Diamyd Medical AB
Conditions Type 1 Diabetes Mellitus
Enrollment 321 participants
Start Date 2022-05-19
Primary Completion 2026-06-24 (estimated)
Study Completion 2026-06-24 (estimated)
Updated on ClinicalTrials.gov 2026-08-26