RecruitingNCT07616206ClinicalTrials.gov record

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

Type 1 Diabetes (T1D)

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 2
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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,

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Double masked

Cadisegliatin 800 mg QD, then Placebo

If a participant is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in 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 participant will cross-over to the placebo QD along with their insulin treatment

Drug: Cadisegliatin 800 mg QD · Drug: Placebo

Placebo, then Cadisegliatin 800 mg QD

If a participant is randomized to receive placebo QD along with their insulin treatment in 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 participant will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment

Drug: Cadisegliatin 800 mg QD · Drug: Placebo

Cadisegliatin 800 mg QD DRUG

Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin

Placebo DRUG

Placebo (insulin alone)

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

To assess the change in Time in Range (TIR)

Time frame: last 2 weeks of the two 6-week treatment periods

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