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

Phase 2Not Yet RecruitingNCT07616206

vTv Therapeutics40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 1 Diabetes (T1D)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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,

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