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Condition / disease
Location
Status: Not yet recruiting

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems

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 manage their diabetes. Participants 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 2 weeks followed by the second double-blind treatment period of 6 weeks where the participants will cross-over to the treatment that they did not receive in the first treatment period.

Participants needed: 40
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: vTv TherapeuticsUpdated: Sep 21, 2026Locations: 1
Eligibility criteria

Participants >= 18 years of age [+5]

Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes,... [+10]