Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study
vTv Therapeutics
Summary
This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Individuals ≥18 years * Diagnosed T1DM with a minimum of 3 years since diagnosis * Has had at least 1 hypoglycemic event of Level 2 (glucose level \<54 mg/dL or \<3 mmol/L, \[CGM or SMBG confirmed\]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening * HbA1c value of \<9.5% at Screening * Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and…
Interventions
- DrugCadisegliatin 800 mg QD
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
- DrugCadisegliatin 800 mg BID
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
- DrugPlacebo
Placebo (insulin alone)
Locations (58)
- Scottsdale Clinical TrialsScottsdale, Arizona
- Baptist Health Center for Clinical ResearchLittle Rock, Arkansas
- Advanced Metabolic Care & Research Institute, Inc. (AMCR)Escondido, California
- MD Studies, IncFountain Valley, California
- AME Clinical ResearchHuntington Beach, California
- 310 Clinical ResearchInglewood, California