Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems (Hybrid CATT1)
22 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Meaghan Marnell
- Número de telefone: (336) 888-0435
- E-mail: clinicaltrials@vtvtherapeutics.com
Locais de estudo
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Georgia
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Atlanta, Georgia, Estados Unidos, 30318
- Atlanta Diabetes Associates
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Investigador principal:
- Bruce W Bode, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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,
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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
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Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin
Outros nomes:
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Comparador de 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
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Placebo (apenas insulina)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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To assess the change in Time in Range (TIR)
Prazo: last 2 weeks of the two 6-week treatment periods
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Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
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last 2 weeks of the two 6-week treatment periods
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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CGM-based metric for glycemic control
Prazo: last 2 weeks of the two 6-week treatment periods
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Time In Tight Range (TITR)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
Prazo: last 2 weeks of the two 6-week treatment periods
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Time Above Range (TAR)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
Prazo: last 2 weeks of the two 6-week treatment periods
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Time Below Range (TBR)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
Prazo: last 2 weeks of the two 6-week treatment periods
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Glucose Management Indicator (GMI)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
Prazo: last 2 weeks of the two 6-week treatment periods
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Glucose variability (GV)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
Prazo: last 2 weeks of the two 6-week treatment periods
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Time in Range (TIR) > 70%
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last 2 weeks of the two 6-week treatment periods
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Change in glucose control after standardized mixed meal tolerance test (MMTT)
Prazo: 12 weeks
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Glucose Peak Plasma Concentration (Cmax) based on study CGM after standardized mixed meal tolerance test (MMTT)
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12 weeks
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Change in glucose control after standardized mixed meal tolerance test (MMTT)
Prazo: 12 weeks
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Glucose Area under the plasma concentration versus time curve (AUC) based on study CGM after standardized mixed meal tolerance test (MMTT)
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12 weeks
|
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Change in glucose control after a standardized exercise test
Prazo: 12 weeks
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Glucose Peak Plasma Concentration (Cmax) based on study CGM after a standardized exercise test
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12 weeks
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Change in glucose control after a standardized exercise test
Prazo: 12 weeks
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Glucose Minimum Plasma Concentration (Cmin) based on study CGM after a standardized exercise test
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12 weeks
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Change in glucose control after a standardized exercise test
Prazo: 12 weeks
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Glucose Area under the plasma concentration versus time curve (AUC) based on study CGM after a standardized exercise test
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12 weeks
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To assess the change in Level 1, Level 2 , and Level 3 hypoglycemic incidence
Prazo: 12 weeks
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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
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12 weeks
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Assess incidence of Serious Adverse Events (SAEs)
Prazo: 14 weeks
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Number of Serious Adverse Events (SAEs)
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14 weeks
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Assess incidence of Treatment Emergent Adverse Events (TEAEs)
Prazo: 14 weeks
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Number of treatment emergent adverse events (TEAEs)
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14 weeks
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Assess incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuation
Prazo: 14 weeks
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Number of treatment emergent adverse events (TEAEs) leading to discontinuation of study drug
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14 weeks
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Assess incidence of Adverse Events of Special Interest (AESIs)
Prazo: 14 weeks
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Number of adverse events of special interest (AESIs)
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14 weeks
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Change from baseline in average daily total insulin dose
Prazo: last week of the two 6-week treatment periods
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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
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last week of the two 6-week treatment periods
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Thomas Strack, MD, vTv Therapeutics LLC
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
15 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TTP399-206
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