The global healthcare community continues to explore innovative ways to manage Type 1 Diabetes Mellitus (T1DM). A new clinical investigation, titled Evaluating Safe Ketone Thresholds to Minimise Ketosis in People with Type 1 Diabetes Using Dapagliflozin, is set to commence shortly, aiming to refine safety parameters and minimise risks associated with ketosis in patients using the drug dapagliflozin (brand name: FORXIGA). This trial is sponsored by leading institutions, including St Vincent’s Hospital Melbourne, Baker Heart and Diabetes Institute, and others.
What changed?
The announcement of this upcoming clinical trial marks significant progress in addressing the risks linked to diabetic ketoacidosis (DKA) in patients with Type 1 Diabetes. This study focuses on the interaction between the drug dapagliflozin, widely used for blood glucose control, and safe ketone level thresholds to minimise ketosis risks.
Who is affected?
This trial is highly relevant for healthcare providers, patients living with Type 1 Diabetes, regulatory professionals monitoring drug safety, and quality experts overseeing clinical processes. The study ensures that dapagliflozin is used safely by identifying operational ketone thresholds.
Clinical objective
The investigation aims to evaluate ketone safety thresholds for Type 1 Diabetes patients using dapagliflozin. DKA is a potentially life-threatening condition linked to elevated ketone levels. Understanding how dapagliflozin interacts with ketone dynamics is vital for improving patient safety and performance reliability.
Sponsors include diverse institutions such as St Vincent’s Hospital Melbourne, Baker Heart and Diabetes Institute, and prominent Australian healthcare organizations like the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Melbourne, Melbourne Health, and Austin Health.
Intervention specifics
Dapagliflozin (FORXIGA), an SGLT2 inhibitor, delivers significant therapeutic benefits for diabetes management but poses risks since it can elevate ketone levels, potentially leading to ketoacidosis. The trial prioritises the establishment of safe parameters to tackle these challenges.
Expected impact
If successful, the trial’s findings could lead to new clinical guidelines for practitioners prescribing dapagliflozin to Type 1 Diabetes patients. Furthermore, regulatory bodies may use the data to enhance drug safety evaluations and modify instructions tied to hyperketonemia risks.
This could also offer insights for future trials targeting similar challenges within SGLT2 inhibitor usage.
FAQ
- What is dapagliflozin? Dapagliflozin, sold as FORXIGA, is an SGLT2 inhibitor used primarily in the treatment of diabetes. It lowers blood sugar by preventing glucose reabsorption in the kidneys.
- Why assess ketone thresholds? Elevated ketone levels can lead to diabetic ketoacidosis. This study seeks to define safer ketone limits when using dapagliflozin.
- Who sponsors the study? Sponsors include St Vincent’s Hospital Melbourne, Baker Heart and Diabetes Institute, NIDDK, University of Melbourne, Melbourne Health, and Austin Health.
- What stage is the trial currently in? The study is marked as “Not yet recruiting” according to ClinicalTrials.gov.
Conclusion
This clinical trial represents a significant step toward reducing the risk of diabetic ketoacidosis in patients with Type 1 Diabetes while using dapagliflozin. Healthcare teams, regulatory experts, and clinical investigators should monitor its progress for insights into emerging safety guidelines and effective diabetes management practices.
Disclaimer
This article is aimed at healthcare professionals and regulatory specialists. It reflects clinical trial information available as of November 6, 2025, and is not intended to serve as legal advice.
ClinicalTrials.gov study details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07225465?term=medical+device