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 groupsSponsors and collaborators
Source ClinicalTrials.gov