Cadisegliatin for Type 1 Diabetes
(Hybrid CATT1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes. Participants using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participants will cross-over to the treatment that they did not receive in the first treatment period.
Who Is on the Research Team?
Maria Alba, MD
Principal Investigator
vTv Therapeutics LLC
Are You a Good Fit for This Trial?
This trial is for people with type 1 diabetes who are already using a hybrid closed loop insulin pump system to manage their blood sugar. Participants must be able to follow the study procedures and use the required devices.Inclusion Criteria
Exclusion 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
First Double-Blind Treatment Period
Participants receive either cadisegliatin or placebo as adjunctive therapy to insulin
Washout Period
Participants undergo a washout period before crossing over to the other treatment arm
Second Double-Blind Treatment Period
Participants cross over to the treatment arm they did not receive in the first period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cadisegliatin
Trial Overview
The study tests whether adding cadisegliatin (800 mg once daily) to regular insulin therapy helps control blood sugar better than a placebo in people with type 1 diabetes using advanced insulin pumps. Each participant tries both treatments during different periods of the trial.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
If a participant is randomized to receive placebo QD along with their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participant will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment
If a participant is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participant will cross-over to the placebo QD along with their insulin treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
vTv Therapeutics
Lead Sponsor
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