A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs.
研究概览
简要总结
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Metformin/DPP4i/SGLT2i
Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.
干预措施: SGLT2 inhibitor (Drug)
Metformin/DPP4i/SGLT2i
Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.
干预措施: DPP-4 inhibitor (Drug)
Metformin/DPP4i/TZD
Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.
干预措施: Thiazolidinedione (Drug)
Metformin/DPP4i/TZD
Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.
干预措施: DPP-4 inhibitor (Drug)
Metformin/SGLT2i/DPP4i
Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.
干预措施: SGLT2 inhibitor (Drug)
Metformin/SGLT2i/DPP4i
Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.
干预措施: DPP-4 inhibitor (Drug)
Metformin/SGLT2i/TZD
Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.
干预措施: SGLT2 inhibitor (Drug)
Metformin/SGLT2i/TZD
Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.
干预措施: Thiazolidinedione (Drug)
结局指标
主要结局
Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs.
时间窗: 24 month
Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration).
次要结局
- Changes in HbA1c(3, 6, (9), 12, 18, and 24 months)
- Changes in FPG(3, 6, (9), 12, 18, and 24 months)
- Percentage of Subjects with HbA1c < 7.0%(3, 6, (9), 12, 18, and 24 months)
- Percentage of Subjects with HbA1c < 6.5%(3, 6, (9), 12, 18, and 24 months)
- Factors influencing HbA1c change at each endpoint for each combination group.(24 month)