Cadisegliatin for Type 1 Diabetes
(CATT1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how well a new treatment, cadisegliatin, works alongside insulin for people with Type 1 Diabetes. The goal is to determine if cadisegliatin can manage blood sugar levels more effectively than insulin alone. Participants will be divided into groups, with some receiving cadisegliatin and others a placebo (a pill with no medicine). The trial seeks individuals who have had Type 1 Diabetes for at least 5 years and have experienced low blood sugar episodes requiring assistance in the past two months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for this trial?
You may need to stop certain medications before joining this trial. Specifically, you cannot have used non-insulin diabetes medications or weight loss drugs within 30 days before the screening. The trial does not specify other medications, so check with the study team for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that cadisegliatin, a treatment under study for type 1 diabetes, appears safe. In previous studies, patients using cadisegliatin reported no major safety issues. The FDA approved further testing of this treatment, indicating trust in its safety.
Although cadisegliatin is not yet approved for type 1 diabetes, ongoing trials aim to ensure its safety for users. So far, the available data reports no major side effects. This is encouraging for prospective participants, as it suggests the treatment has been safe for most in earlier research.12345Why are researchers excited about this trial's treatments?
Cadisegliatin is unique because it offers a potential new approach for managing Type 1 diabetes. Unlike standard treatments that primarily focus on insulin replacement, Cadisegliatin targets glucose regulation through a novel mechanism. Researchers are excited about its ability to offer more precise blood sugar control, which could reduce the need for insulin adjustments and enhance overall diabetes management. With dosing options of once or twice daily, Cadisegliatin also provides flexibility that could fit better into patients' lifestyles.
What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?
Research has shown that cadisegliatin is being studied to help people with Type 1 Diabetes manage blood sugar levels more effectively. In this trial, participants will receive either cadisegliatin at varying dosages or a placebo. Cadisegliatin aids the body in using sugar more efficiently. So far, participants have tolerated it well, and it has not increased the risk of diabetic ketoacidosis, a serious diabetes complication. Nearly 600 people have tried cadisegliatin, and it appears promising in reducing serious low blood sugar events. These findings suggest cadisegliatin could complement insulin therapy in managing Type 1 Diabetes.23467
Who Is on the Research Team?
Thomas Strack, MD
Principal Investigator
vTv Therapeutics
Are You a Good Fit for This Trial?
Adults over 18 with Type 1 Diabetes for at least 5 years, who've had a serious low blood sugar event recently. They must have an HbA1c level below 9.5% and be on continuous or multiple daily insulin injections without changing their treatment method throughout the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Training and Insulin Adjustment
Participants undergo device training and insulin adjustment
Baseline
Participants enter a baseline period before treatment
Treatment
Participants receive cadisegliatin or placebo for 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cadisegliatin
Trial Overview
The trial is testing Cadisegliatin as an extra treatment alongside insulin for Type 1 Diabetes. Participants will either receive Cadisegliatin twice daily (BID), once daily (QD), or a placebo to compare effects.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.
The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.
The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
vTv Therapeutics
Lead Sponsor
Citations
1.
ir.vtvtherapeutics.com
ir.vtvtherapeutics.com/news-releases/news-release-details/vtv-therapeutics-announces-first-study-participant-randomizedPress Release - Investor Overview - vTv Therapeutics Inc.
vTv Therapeutics Announces First Study Participant Randomized in CATT1 Phase 3 Trial of Cadisegliatin in Type 1 Diabetes | vTv Therapeutics Inc.
2.
breakthrought1d.org
breakthrought1d.org/news-and-updates/the-inside-scoop-on-the-catt1-clinical-trial/The inside scoop on the CATT1 clinical trial
Nearly 600 participants have received cadisegliatin so far—it's been well-tolerated and hasn't increased the risk of diabetic ketoacidosis (DKA) ...
Study Details | NCT06334133 | Cadisegliatin as Adjunctive ...
A 26-week, Phase 3 trial designed to measure the relative efficacy of adjunctive treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 ...
FDA removes hold on vTv's cadisegliatin clinical programme
The FDA has removed the clinical hold on vTv Therapeutics' cadisegliatin clinical programme, including the Phase III CATT1 trial for T1D.
5.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/VTVT-Q/pressreleases/35738371/vtv-therapeutics-promising-phase-3-study-on-cadisegliatin-for-type-1-diabetes/vTv Therapeutics' Promising Phase 3 Study on ...
' The study aims to evaluate the efficacy of cadisegliatin, a glucokinase activator, as an adjunctive therapy to insulin in patients with Type 1 ...
6.
ir.vtvtherapeutics.com
ir.vtvtherapeutics.com/news-releases/news-release-details/vtv-therapeutics-announces-fda-has-lifted-clinical-holdvTv Therapeutics Announces FDA has Lifted Clinical Hold on ...
Cadisegliatin has the potential to be the first oral adjunct therapy for type 1 diabetes ... safety data. By shortening the trial from 12 to 6 months, the ...
cadisegliatin (TTP399) / vTv Therapeutics
Dorzagliatin enhances GLP-1 secretion by restoring the function of intestinal L-cells (EASD 2025) - "Our study reveals the unique ability of dorzagliatin to ...
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