Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorvTv Therapeutics
About this trial
This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
Eligibility criteria
Qualifiers
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
Disqualifiers
Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease
Has been hospitalized for DKA within 3 months prior to Screening
Has uncontrolled hypothyroidism or hyperthyroidism
History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight
Trial design
Treatments tested in this trial
- Cadisegliatin 800 mg QD
- Cadisegliatin 800 mg BID
- Placebo
Treatment groups
150 Participants
are divided into 3 treatment groupsLocations
61Puerto Rico
Solace Clinical Research00907, San Juan Puerto Rico
United States
Arizona
Scottsdale Clinical Trials85260, Scottsdale United States
Arkansas
Baptist Health Center for Clinical Research72205, Little Rock United States
California
Advanced Metabolic Care & Research Institute, Inc. (AMCR)92025, Escondido United States
Sponsors and collaborators
vTv Therapeutics
Lead sponsor
Source ClinicalTrials.gov