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Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems (Hybrid CATT1)

22 mai 2026 mis à jour par: vTv Therapeutics

Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Georgia
      • Atlanta, Georgia, États-Unis, 30318
        • Atlanta Diabetes Associates
        • Chercheur principal:
          • Bruce W Bode, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Key Inclusion Criteria:

  • 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
  • Willing to wear a study provided CGM for study duration
  • Capable of participating in a 30-minute lasting exercise test

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 incliuding but not limited to HIV or active Hep B or Hep C
  • 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,

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cadisegliatin 800 mg QD: Double Blind, Randomized Crossover Trial Design
If a patient 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 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the placebo QD along with their insulin treatment arm
Médicament: Cadisegliatin 800 mg QD
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin
Autres noms:
  • TTP399
Comparateur placebo: Placebo: Double Blind, Randomized Crossover Trial Design
If a patient 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 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment arm
Médicament: Placebo
Placebo (insuline seule)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
To assess the change in Time in Range (TIR)
Délai: 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
last 2 weeks of the two 6-week treatment periods

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
CGM-based metric for glycemic control
Délai: last 2 weeks of the two 6-week treatment periods
Time In Tight Range (TITR)
last 2 weeks of the two 6-week treatment periods
CGM-based metric for glycemic control
Délai: last 2 weeks of the two 6-week treatment periods
Time Above Range (TAR)
last 2 weeks of the two 6-week treatment periods
CGM-based metric for glycemic control
Délai: last 2 weeks of the two 6-week treatment periods
Time Below Range (TBR)
last 2 weeks of the two 6-week treatment periods
CGM-based metric for glycemic control
Délai: last 2 weeks of the two 6-week treatment periods
Glucose Management Indicator (GMI)
last 2 weeks of the two 6-week treatment periods
CGM-based metric for glycemic control
Délai: last 2 weeks of the two 6-week treatment periods
Glucose variability (GV)
last 2 weeks of the two 6-week treatment periods
CGM-based metric for glycemic control
Délai: last 2 weeks of the two 6-week treatment periods
Time in Range (TIR) > 70%
last 2 weeks of the two 6-week treatment periods
Change in glucose control after standardized mixed meal tolerance test (MMTT)
Délai: 12 weeks
Glucose Peak Plasma Concentration (Cmax) based on study CGM after standardized mixed meal tolerance test (MMTT)
12 weeks
Change in glucose control after standardized mixed meal tolerance test (MMTT)
Délai: 12 weeks
Glucose Area under the plasma concentration versus time curve (AUC) based on study CGM after standardized mixed meal tolerance test (MMTT)
12 weeks
Change in glucose control after a standardized exercise test
Délai: 12 weeks
Glucose Peak Plasma Concentration (Cmax) based on study CGM after a standardized exercise test
12 weeks
Change in glucose control after a standardized exercise test
Délai: 12 weeks
Glucose Minimum Plasma Concentration (Cmin) based on study CGM after a standardized exercise test
12 weeks
Change in glucose control after a standardized exercise test
Délai: 12 weeks
Glucose Area under the plasma concentration versus time curve (AUC) based on study CGM after a standardized exercise test
12 weeks
To assess the change in Level 1, Level 2 , and Level 3 hypoglycemic incidence
Délai: 12 weeks
Number of events of Level 1, Level 2, and Level 3 hypoglycemia as determined by CGM and adjudicated level 3 hypoglycemic events per patient year in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
12 weeks
Assess incidence of Serious Adverse Events (SAEs)
Délai: 14 weeks
Number of Serious Adverse Events (SAEs)
14 weeks
Assess incidence of Treatment Emergent Adverse Events (TEAEs)
Délai: 14 weeks
Number of treatment emergent adverse events (TEAEs)
14 weeks
Assess incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuation
Délai: 14 weeks
Number of treatment emergent adverse events (TEAEs) leading to discontinuation of study drug
14 weeks
Assess incidence of Adverse Events of Special Interest (AESIs)
Délai: 14 weeks
Number of adverse events of special interest (AESIs)
14 weeks
Change from baseline in average daily total insulin dose
Délai: last week of the two 6-week treatment periods
Change from baseline in average daily total insulin dose in units (IU) based on manual entry in eDiary records from participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
last week of the two 6-week treatment periods

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

vTv Therapeutics

Les enquêteurs

  • Directeur d'études: Thomas Strack, MD, vTv Therapeutics LLC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

15 mai 2026

Première soumission répondant aux critères de contrôle qualité

22 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TTP399-206

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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