Trial results for a novel endoscopic intervention for Type 2 Diabetes were posted on ClinicalTrials.gov on 2026-01-22. The study, involving 65 participants, investigated the safety and feasibility of the DyaMX device, showing reductions in HbA1c levels.
Background
Type 2 Diabetes is a chronic metabolic condition characterized by high blood sugar levels, often resulting from insulin resistance and insufficient insulin production. It affects millions globally and can lead to serious complications such as heart disease, kidney disease, nerve damage, and vision loss if not adequately managed. Current treatments typically involve lifestyle modifications, oral medications, and injectable therapies, including insulin. However, many individuals struggle to achieve optimal glycemic control with these approaches alone. Novel interventions, particularly those targeting the gastrointestinal tract, are being explored as potential options for patients whose diabetes remains inadequately controlled, aiming to improve metabolic health and reduce the burden of the disease.
Trial design
This completed open-label study, designated as Phase NA, enrolled a total of 65 participants with Type 2 Diabetes who were inadequately controlled on glucose-lowering medications. The trial assessed the safety and feasibility of the DyaMX device for endoscopic duodenal mucosal regeneration. Participants were divided into two cohorts: an Intervention-Non-Insulin Cohort and an Intervention-Insulin Cohort, based on their existing medication regimen.
Key results
The trial reported key measurements related to safety and glycemic control:
- Number of Participants With Device- or Procedure-related Serious Adverse Events (SAE):
- In the Intervention-Non-Insulin Cohort, 0 participants experienced a device- or procedure-related SAE.
- In the Intervention-Insulin Cohort, 1 participant experienced a device- or procedure-related SAE.
- HbA1c by Post Procedure Follow-up Visit:
- For the Intervention-Non-Insulin Cohort, mean HbA1c levels were reported as 8.8% (Standard Deviation 0.9), 7.7% (Standard Deviation 1.2), 7.8% (Standard Deviation 2.4), and 7.7% (Standard Deviation 2.4).
- For the Intervention-Insulin Cohort, mean HbA1c levels were reported as 8.5% (Standard Deviation 0.8), 7.9% (Standard Deviation 0.99), 8.1% (Standard Deviation 1.0), and 7.6% (Standard Deviation 1.0).
- Fasting Plasma Glucose by Visit:
- For the Intervention-Non-Insulin Cohort, the mean Fasting Plasma Glucose was 10.1 mmol/L (Standard Deviation 2.7).
- For the Intervention-Insulin Cohort, the mean Fasting Plasma Glucose was 8.6 mmol/L (Standard Deviation 1.6).
What this means
The results indicate that the DyaMX endoscopic intervention demonstrated a favorable safety profile, with a low incidence of device- or procedure-related serious adverse events across both cohorts. The reported HbA1c measurements suggest a reduction in average blood glucose levels following the procedure in both the non-insulin and insulin-treated cohorts. While these findings are from an open-label study primarily assessing safety and feasibility, the observed improvements in glycemic control, alongside the safety data, support further investigation into this novel approach for individuals with Type 2 Diabetes who have not achieved adequate control with conventional therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04725890, titled "Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes", were posted on 2026-01-22 on clinicaltrials.gov.