Exciting Breakthrough in Diabetes Treatment!

A groundbreaking phase 3 clinical trial has kicked off, aiming to test cadisegliatin, a potential first-of-its-kind oral medication for Type 1 diabetes. This innovative treatment seeks to enhance blood glucose control and lower the risk of dangerous low blood sugar episodes, a common concern for those living with this chronic condition.

What is Type 1 Diabetes?

Type 1 diabetes is an autoimmune disorder where the immune system attacks and destroys insulin-producing cells in the pancreas. An estimated 2 million people in the U.S. are affected, and many experience hypoglycemia—a critical issue where blood sugar levels drop to hazardous lows. Shockingly, around 4% of insulin users face this complication, often only seeking medical help when their situation becomes critical.

Experts Weigh In!

Dr. Klara Klein, an assistant professor of medicine at the University of North Carolina, notes the pressing need for therapies that can improve glycemic levels without heightening the risk of ketoacidosis or hypoglycemia. "People with Type 1 diabetes are constantly balancing the line between hyperglycemia and hypoglycemia," she emphasized.

How Does Cadisegliatin Work?

In preliminary studies, cadisegliatin has shown a targeted effect on the liver, boosting glucokinase activity independent of insulin. This enzyme is crucial for maintaining healthy blood sugar levels.

Promising Results from Previous Trials!

The drug has demonstrated a strong safety profile in over 500 patients across six months of treatment. A phase 2 trial revealed that combining cadisegliatin with insulin led to a staggering 50% reduction in symptomatic low blood sugar episodes, without any cases of ketoacidosis. Patients also saw a 36% decrease in hemoglobin A1C levels compared to insulin alone—remarkably, 40% managed to lower their total daily insulin needs!

What's Next for the CATT1 Phase 3 Trial?

This extensive trial, named CATT1, is set to enroll around 150 patients across 25 sites in the U.S. Researchers will compare two cadisegliatin dosages—800 mg once versus twice daily—against insulin alone in individuals undergoing multiple daily injections or continuous subcutaneous insulin infusion. Continuous glucose monitors will assist in monitoring each patient's progress.

Key Goals and Timelines!

The main objective is to track the occurrence of severe low blood sugar incidents in patients treated with cadisegliatin versus those receiving just insulin. Additional metrics will examine reductions in hemoglobin A1C levels, blood sugar control time, and cases of ketoacidosis. Excitingly, topline results from this trial are anticipated by the latter half of 2026!

Overcoming Challenges!

Earlier, the FDA imposed a clinical hold on the trial in July 2024 due to findings in a study concerning the drug's absorption and processing in the body. Thankfully, the hold was lifted in March 2025 when investigators determined that the issue arose from a temporary experimental defect. Changes to the CATT1 trial have now shortened its duration from one year to just six months, streamlining the process for this revolutionary treatment.