Join Trial Testing New Oral Medication for Type 1 Diabetes
If you have type 1 diabetes and struggle with low blood sugar, you may be eligible for a clinical trial testing cadisegliatin, a new oral medication that helps reduce hypoglycemia.
Note: As of July 26, this trial has been placed on a clinical hold by the FDA and enrollment has been paused.
Clinical Trials Identifier: NCT06334133
Trial Name: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes (CATT1)
Diabetes Type: Type 1 diabetes
Trial Sponsor: vTv Therapeutics
What is the aim of the study?
This study is testing whether the oral medication cadisegliatin can help reduce hypoglycemia in people with type 1 diabetes.
Cadisegliatin is a type of medication categorized as a liver-selective glucokinase activator. It helps the liver function normally when glucose levels are high. Specifically, cadisegliatin traps glucose inside liver cells and promotes glucose uptake and storage.
Because cadisegliatin works differently than other diabetes medications, it may be an ideal adjunctive therapy for type 1 diabetes – that is, a non-insulin medication that can be used alongside insulin to help manage blood sugar. There is currently only one adjunctive therapy approved for type 1 diabetes: Symlin (pramlintide), an injectable medication that must be taken before each meal.
How does the trial work?
Researchers are recruiting 150 participants with type 1 diabetes who have experienced at least one recent episode of hypoglycemia (low blood sugar) in the past two months.
Participants will be randomized to one of three groups for the one-year trial: cadisegliatin once daily, cadisegliatin twice daily, or placebo. Beyond hypoglycemia, the study will also examine the effects of cadisegliatin treatment on A1C, continuous glucose monitoring (CGM) metrics, diabetic ketoacidosis, insulin dosing, and body weight.
Why is the cadisegliatin trial important?
Many people with type 1 diabetes experience hypoglycemia, which can disrupt everyday life and be dangerous if left untreated. Frequent low blood sugar episodes can lead to complications like hypoglycemia unawareness, dementia and cognitive dysfunction, and heart problems.
Previous research has shown promising results for cadisegliatin in type 1 diabetes. In an earlier trial, cadisegliatin led to a 40% reduction in the frequency of severe and symptomatic hypoglycemic events.
Based on these findings, cadisegliatin received breakthrough therapy designation from the FDA. This means the FDA designated cadisegliatin as a drug that has an advantage over existing options for people with type 1 diabetes.
According to vTv Therapeutics, cadisegliatin has been studied in nearly 600 participants to date, including those with type 2 diabetes.
Are you interested in participating?
You may be eligible if you:
- Are 18 years or older and have been diagnosed with type 1 diabetes for at least five years
- Have an A1C under 9.5%
- Have experienced at least one hypoglycemic event with glucose below 54 mg/dL or a severe hypoglycemic event in the past two months
- Are currently using an insulin pump or multiple daily injections
- Have used a CGM for at least three months
People who use automated insulin delivery (AID) systems or take non-insulin diabetes medications (such as SGLT-2s, DPP-4s, GLP-1s, or metformin) are not eligible for this study. See a full list of inclusion and exclusion criteria here.
This study is recruiting in California, Colorado, Florida, Georgia, Iowa, North Carolina, Oregon, and Texas. To enroll or learn more about this study, contact Dr. Jennifer Freeman at [email protected] or (336) 888-0435.
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