IA Trial Radar
O estudo clínico NCT06838286 (TRIO) para Diabetes mellitus, tipo 2 está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Voltar à pesquisa

Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes (TRIO) 10.000

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06838286 (TRIO) é um estudo observacional para Diabetes mellitus, tipo 2. Seu status atual é: em recrutamento. O estudo começou em 16 de março de 2024 e pretende incluir 10.000 participantes. Coordenado por Chong Kun Dang Pharmaceutical e deve ser concluído em 31 de dezembro de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 20 de fevereiro de 2025.
Resumo
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Descrição detalhada
The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.

Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglyce...

Mostrar mais
Título oficial

A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients

Condições médicas
Diabetes mellitus, tipo 2
Outros IDs do estudo
  • TRIO
  • D141_01DM2303
Número NCT
NCT06838286
Data de início (real)
2024-03-16
Última atualização postada
2025-02-20
Data de conclusão (estimada)
2029-12-31
Inscrição (estimada)
10.000
Tipo de estudo
Observacional
Status
Em recrutamento
Palavras-chave
Type 2 diabetes mellitus
Korean patients
Observational study
OAD triple therapy
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Metformin/DPP4i/SGLT2i
Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.
SGLT2 inhibitor
SGLT2 inhibitor class of drugs
DPP-4 inhibitor
DPP4 inhibitor class of drugs
Metformin/DPP4i/TZD
Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.
Thiazolidinedione
Thiazolidinedione class of drugs
DPP-4 inhibitor
DPP4 inhibitor class of drugs
Metformin/SGLT2i/DPP4i
Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.
SGLT2 inhibitor
SGLT2 inhibitor class of drugs
DPP-4 inhibitor
DPP4 inhibitor class of drugs
Metformin/SGLT2i/TZD
Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.
SGLT2 inhibitor
SGLT2 inhibitor class of drugs
Thiazolidinedione
Thiazolidinedione class of drugs
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs.
Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration).
24 month
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Changes in HbA1c
Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Changes in FPG
Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 7.0%
Percentage of Subjects with HbA1c \< 7.0% in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 6.5%
Percentage of Subjects with HbA1c \< 6.5% in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Factors influencing HbA1c change at each endpoint for each combination group.
demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.
24 month
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
19 Years
Sexos elegíveis
Todos
  1. Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
  2. Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
  3. 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
  4. Voluntarily give written informed consent after being told about the study.

  1. Patients with type 1 diabetes and secondary diabetes.
  2. Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
  3. Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
  4. End-stage renal disease and hemodialysis patients.
  5. diabetic ketoacidosis Patients.
  6. Pregnant and lactating women.
  7. Patients who are contraindicated by any of the "Precautions for Use" in the license for the drug being administered during the study, given the observational nature of the study under routine practice.
  8. Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
  9. Anyone else deemed by the investigator to be unsuitable for participation in the study.
Chong Kun Dang Pharmaceutical logoChong Kun Dang Pharmaceutical
Contato central do estudo
Contato: Soo Lim, M.D, Ph.D., 82-2-6373-0773, [email protected]
1 Locais do estudo em 1 países

Gyeonggi-do

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea
Soo Lim, M.D, Ph.D., Contato, 1588-3369, [email protected]
Em recrutamento