TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manager their diabetes. Patients using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the treatment arm that they did not receive in the first treatment period.
Participants >= 18 years of age
Fasting plasma C-peptide levels <0.6 ng/ml
Average TIR < 70% at the end of the screening period
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
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