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Cadisegliatin: 52 Week Double Blind Treatment Period - 800 mg BID for Type 1 Diabetes (CATT1 Trial)

Phase 3
Waitlist Available
Research Sponsored by vTv Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 and 52 weeks
Awards & highlights

Summary

This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
11-item/Short Form Hypoglycemia Fear Scale
8-item Diabetes Distress Scale (participant and partner or family member)
Change in incidence of Level 2 or Level 3 hypoglycemia
+15 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cadisegliatin: 52 Week Double Blind Treatment Period - 800 mg QDExperimental Treatment1 Intervention
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 52-week treatment period.
Group II: Cadisegliatin: 52 Week Double Blind Treatment Period - 800 mg BIDExperimental Treatment1 Intervention
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 52-week treatment period.
Group III: Placebo: 52 Week Double Blind Treatment PeriodPlacebo Group1 Intervention
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 52-week treatment period.

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Who is running the clinical trial?

vTv TherapeuticsLead Sponsor
13 Previous Clinical Trials
2,543 Total Patients Enrolled
Thomas Strack, MDStudy DirectorvTv Therapeutics
~100 spots leftby Jun 2025
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