NCT06334133

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: vTv Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.

Detailed description

Study TTP399-302 is 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 hypoglycemia in participants with Type 1 Diabetes Mellitus compared to placebo (insulin alone) over 26 weeks of continuous therapy.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Cadisegliatin 800 mg QD	Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
DRUG	Cadisegliatin 800 mg BID	Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
DRUG	Placebo	Placebo (insulin alone)

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2024-03-27
• Last updated: 2026-03-12

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study