Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems (Hybrid CATT1)
22 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Meaghan Marnell
- Número de teléfono: (336) 888-0435
- Correo electrónico: clinicaltrials@vtvtherapeutics.com
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30318
- Atlanta Diabetes Associates
-
Investigador principal:
- Bruce W Bode, MD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
|
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin
Otros nombres:
|
|
Comparador de placebos: 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
|
Placebo (insulina solo)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To assess the change in Time in Range (TIR)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
CGM-based metric for glycemic control
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 14 weeks
|
Number of Serious Adverse Events (SAEs)
|
14 weeks
|
|
Assess incidence of Treatment Emergent Adverse Events (TEAEs)
Periodo de tiempo: 14 weeks
|
Number of treatment emergent adverse events (TEAEs)
|
14 weeks
|
|
Assess incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuation
Periodo de tiempo: 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)
Periodo de tiempo: 14 weeks
|
Number of adverse events of special interest (AESIs)
|
14 weeks
|
|
Change from baseline in average daily total insulin dose
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Thomas Strack, MD, vTv Therapeutics LLC
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de abril de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
15 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TTP399-206
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .