TTP399-206 is a 20 week, Phase 2a trial designed to evaluate efficacy and safety of cadisegliatin in participants with T1D who are using hybrid closed loop (HCL) systems to manage their condition to gather preliminary data to understand how cadisegliatin performs in an HCL setting.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants \>= 18 years of age
Fasting C-peptide levels \<0.6 ng/ml
Average TIR \< 70% recorded on their personal CGM data collected over the past 7 days prior to Visit 1
Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration
Willing to wear a study provided CGM for study duration
Total bilirubin ≤2×ULN, ALT and AST ≤3×ULN
You may not be if
Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.
Have been hospitalized for DKA within 3 months
Have uncontrolled hypothyroidism or hyperthyroidism
Have QTcF interval \> 450 msec for males or \> 470 msec for females
Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias
Have persistent, uncontrolled hypertension
Have clinically significant cardiovascular or cerebrovascular disease
Have proliferative retinopathy or maculopathy requiring acute treatment
Have a serious concomitant systemic disorder including but not limited to HIV or active Hep B or Hep C
Have been diagnosed and/or treated for malignancy within 3 years
Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,
Clareo Health | Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems
