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

ConditionType 1 Diabetes (T1D)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorvTv Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Cadisegliatin 800 mg QD
Drug
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin
Placebo
Drug
Placebo (insulin alone)

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Cadisegliatin 800 mg QD: Double Blind, Randomized Crossover Trial DesignExperimental treatment 1 intervention

Group B: Placebo: Double Blind, Randomized Crossover Trial DesignPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

To assess the change in Time in Range (TIR)

Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo

Time frame