Diamyd phase 3 type 1 diabetes precision medicine trial receives positive interim analysis

Phase 3 type 1 diabetes precision medicine trial receives positive interim analysis | Image Credit: © Michael O'Neill - © Michael O'Neill - stock.adobe.com.

The DIAGNODE-3 phase 3 clinical trial (NCT05018585) evaluating rhGAD65/alum (Diamyd; Diamyd Medical) has received a favorable recommendation to continue, without any modifications, from an independent Data Safety Monitoring Board (DSMB) according to a press release from Diamyd Medical.^1,2

The interim analysis evaluated data at a 6-month time point from 74 patients enrolled in the trial to assess the likelihood of achieving the preservation of endogenous insulin-producing capacity measured as C-peptide, one of the study's co-primary endpoints. Overall, the trial's objective is to evaluate safety and efficacy of 3 intranodal injections of 4 μg of Diamyd compared to placebo, in addition of 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, according to available study details via ClinicalTrials.gov.^1,2

The confirmatory, 2-arm, randomized, double-blind, multicenter, and placebo-controlled trial will enroll up to 330 individuals aged 12 to 29 years who have been diagnosed with type 1 diabetes (T1D) within 6 months and carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for T1D.¹

The patient population in DIAGNODE-3 is based on the clinical results from the phase 2a and phase 2b DIAGNODE-1 (NCT02352974) and DIAGNODE-2 (NCT03345004) trials, in addition to a meta-analysis that included data from more than 600 individuals from previous phase 2 and phase 3 trials using Diamyd.¹

"The trial design provides a high probability of reaching its co-primary endpoints of preservation of endogenous insulin-producing capacity measured as stimulated C-peptide and improved blood glucose control as determined by HbA1c," wrote Diamyd in the press release.¹

"We are extremely pleased with the DSMB's recommendation to continue the DIAGNODE-3 trial as planned," said Ulf Hannelius, CEO, Diamyd Medical. "This positive outcome reaffirms our confidence in the potential for Diamyd to address an unmet medical need in Type 1 Diabetes. We are committed to advancing this promising therapy as part of a process recently approved by the [FDA], allowing for an accelerated approval pathway for Diamyd. We look forward to achieving our next milestones towards this goal."¹

Diamyd to improve glycemic control in recently diagnosed stage 3 T1D patients with the genotype HLA DR3-DQ2 was granted Fast Track designation by the FDA in February 2024.³

References:

1. Diamyd Medical announces positive interim analysis results for phase 3 trial in type 1 diabetes. Diamyd Medical. Press release. July 30, 2024. Accessed August 1, 2024. https://www.prnewswire.com/news-releases/diamyd-medical-announces-positive-interim-analysis-results-for-phase-3-trial-in-type-1-diabetes-302210231.html
2. 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 (DIAGNODE-3). ClinicalTrials.gov. Updated July 19, 2024. Accessed August 1, 2024. https://clinicaltrials.gov/study/NCT05018585
3. Diamyd Medical receives US FDA Fast Track designation for Diamyd. Diamyd Medical. February 15, 2024. Accessed August 1, 2024. https://www.diamyd.com/docs/pressClips.aspx?ClipID=4751158