Estudo coreano sobre segurança e eficácia da terapia tripla de OAD no diabetes tipo 2 (TRIO)
Um estudo de observação multicêntrico, prospectivo e não intervencional para avaliar a segurança e a eficácia da terapia tripla de OAD em pacientes com mellitus diabético do tipo 2 coreano
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
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 hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.
The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Soo Lim, M.D, Ph.D.
- Número de telefone: 82-2-6373-0773
- E-mail: limsoo@snu.ac.kr
Locais de estudo
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Coréia do Sul
- Recrutamento
- Seoul National University Bundang Hospital
-
Contato:
- Soo Lim, M.D, Ph.D.
- Número de telefone: 1588-3369
- E-mail: limsoo@snu.ac.kr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.
Descrição
Inclusion Criteria:
- Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
- Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
- 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
- Voluntarily give written informed consent after being told about the study.
Exclusion Criteria:
- Patients with type 1 diabetes and secondary diabetes.
- Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
- Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
- End-stage renal disease and hemodialysis patients.
- diabetic ketoacidosis Patients.
- Pregnant and lactating women.
- 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.
- Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
- Anyone else deemed by the investigator to be unsuitable for participation in the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Metformin/DPP4i/SGLT2i
Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs. |
SGLT2 inhibitor class of drugs DPP4 inhibitor class of drugs |
|
Metformin/DPP4i/TZD
Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs. |
DPP4 inhibitor class of drugs Thiazolidinedione class of drugs |
|
Metformin/SGLT2i/DPP4i
Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs. |
SGLT2 inhibitor class of drugs DPP4 inhibitor class of drugs |
|
Metformin/SGLT2i/TZD
Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs. |
SGLT2 inhibitor class of drugs Thiazolidinedione class of drugs |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin
Prazo: Up to 24 months
|
Safety will be assessed based on all adverse events, laboratory test results, and vital signs collected after enrollment during the study period. |
Up to 24 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in HbA1c
Prazo: 3, 6, (9), 12, 18, and 24 months
|
Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group |
3, 6, (9), 12, 18, and 24 months
|
|
Changes in FPG
Prazo: 3, 6, (9), 12, 18, and 24 months
|
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%
Prazo: 3, 6, (9), 12, 18, and 24 months
|
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%
Prazo: 3, 6, (9), 12, 18, and 24 months
|
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 time point in each combination group.
Prazo: 3, 6, (9), 12, 18, and 24 months
|
demographics, previous hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc. |
3, 6, (9), 12, 18, and 24 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in Weight
Prazo: 3, 6, (9), 12, 18, 24 months
|
Changes in Weight(kg) Compared to Baseline in Each Combination Group |
3, 6, (9), 12, 18, 24 months
|
|
Changes in waist circumference
Prazo: 12 and 24 months
|
Changes in waist circumference(cm) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Changes in body composition(protein mass)
Prazo: 12 and 24 months
|
Change in total protein mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in body composition(protein mass)
Prazo: 12 and 24 months
|
Change in protein mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in body composition(body fat)
Prazo: 12 and 24 months
|
Change in body fat mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in body composition(mineral mass)
Prazo: 12 and 24 months
|
Change in mineral mass from baseline in each combination group, as measured using InBody 770 or a higher model. |
12 and 24 months
|
|
Changes in Fatty Liver Index
Prazo: 6, 12, 18, and 24 months
|
Changes in Fatty Liver Index compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in AST
Prazo: 6, 12, 18, and 24 months
|
Changes in AST(IU/L) Compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in ALT
Prazo: 6, 12, 18, and 24 months
|
Changes in ALT(IU/L) Compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes Platelet Levels
Prazo: 6, 12, 18, and 24 months
|
Changes in Platelet(10^3/uL) Levels Compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG)
Prazo: 6, 12, 18, and 24 months
|
Change in Total cholesterol, LDL-C, HDL-C, TG(mg/dL) compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in Insulin-Related Test Levels(HOMA-IR)
Prazo: 12 and 24 months
|
Changes in HOMA-IR compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Changes in Insulin-Related Test Levels(HOMA-β)
Prazo: 12 and 24 months
|
Changes in HOMA-β(%) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Changes in eGFR
Prazo: 6, 12, 18, and 24 months
|
Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Changes in UACR
Prazo: 6, 12, 18, and 24 months
|
Changes in UACR(mg/g) compared to Baseline in Each Combination Group |
6, 12, 18, and 24 months
|
|
Change in hsCRP
Prazo: 12 and 24 months
|
Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Change in ProBNP(or NT-ProBNP)
Prazo: 12 and 24 months
|
Change in ProBNP(or NT-ProBNP)(pg/mL) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Change in PP2 Compared to Baseline in Each Combination Group
Prazo: 3, 6, (9), 12, 18, and 24 months
|
Change in PP2(mg/dL) compared to Baseline in Each Combination Group. |
3, 6, (9), 12, 18, and 24 months
|
|
Incidence Rate of Major Adverse Cardiovascular Events(MACE)
Prazo: 24 month
|
Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group |
24 month
|
|
Incidence Rate of Diabetic Microvascular Events
Prazo: 24 month
|
Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group |
24 month
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Doenças Nutricionais e Metabólicas
- Diabetes Mellitus, Tipo 2
- Efeitos fisiológicos das drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes hipoglicemiantes
- Inibidores de Protease
- Inibidores Enzimáticos
- Ações farmacológicas
- Ações e usos químicos
- Inibidores do transportador de sódio-glicose 2
- 2,4-tiazolidinediona
- Inibidores da dipeptidil-peptidase IV
Outros números de identificação do estudo
- D141_01DM2303
Plano para dados de participantes individuais (IPD)
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