제 2 형 당뇨병에서 OAD 삼중 요법의 안전성 및 효과에 대한 한국 연구 (TRIO)
한국 제 2 형 당뇨병 환자에서 OAD 삼중 요법의 안전성 및 효과를 평가하기위한 다기관, 전향 적, 비교 전통적 관찰 연구
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Soo Lim, M.D, Ph.D.
- 전화번호: 82-2-6373-0773
- 이메일: limsoo@snu.ac.kr
연구 장소
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, 대한민국
- 모병
- Seoul National University Bundang Hospital
-
연락하다:
- Soo Lim, M.D, Ph.D.
- 전화번호: 1588-3369
- 이메일: limsoo@snu.ac.kr
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in HbA1c
기간: 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
기간: 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%
기간: 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%
기간: 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.
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Weight
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 12 and 24 months
|
Changes in HOMA-β(%) compared to Baseline in Each Combination Group |
12 and 24 months
|
|
Changes in eGFR
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 24 month
|
Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group |
24 month
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- D141_01DM2303
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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