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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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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, then PlaceboExperimental treatment 2 interventions
Group B: Placebo, then Cadisegliatin 800 mg QDExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
last 2 weeks of the two 6-week treatment periods

Secondary outcomes

1

CGM-based metric for glycemic control

Time In Tight Range (TITR)

Time frame
last 2 weeks of each treatment period
2

CGM-based metric for glycemic control

Time Above Range (TAR)

Time frame
last 2 weeks of each treatment period
3

CGM-based metric for glycemic control

Time Below Range (TBR)

Time frame
last 2 weeks of each treatment period
4

CGM-based metric for glycemic control

Glucose Management Indicator (GMI)

Time frame
last 2 weeks of each treatment period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

vTv Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: