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.
Clinical Trials Identifier: NCT06334133
Trial Status: Recruiting
Trial Name: Cadisegliatin as Adjunctive Therapy to Insulin in Participants With 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 medication categorized as a liver-selective glucokinase activator. It is intended to help improve liver function when glucose levels are high. Specifically, cadisegliatin is thought to trap glucose inside liver cells and promote glucose uptake and storage.
Because cadisegliatin works differently from other diabetes medications, it may be useful as a non-insulin medication that can be used alongside insulin to help manage blood sugar. There is currently only one such therapy approved for type 1 diabetes: Symlin (pramlintide), an injectable medication that must be taken before each meal.
How does the trial work?
Participants will be randomly assigned to the treatment group or the placebo group. Those assigned to a treatment group will receive 800 mg of cadisegliatin, either once per day or twice per day, for 26 weeks. Both the treatment and placebo groups will continue using insulin during this time. They must have used a CGM device for at least the prior three months.
Before the treatment period, participants will complete a 14-day screening period, followed by a 28-day training with an insulin pump or multiple daily insulin injections (but not an automated insulin delivery system) and an insulin adjustment period, and then a 28-day baseline period.
To determine the safety and effectiveness of cadisegliatin, researchers will measure the number of level 2 or level 3 hypoglycemic events, along with changes in A1C, time in range, DKA events, average total daily insulin, 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, 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 hypoglycemic events.
Based on these findings, cadisegliatin received a 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 SGLT2s, DPP-4s, GLP-1s, or metformin) are not eligible for this study.
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 clinicaltrials@vtvtherapeutics.com or (336) 888-0435.
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