- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07635953
New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes
Combination Therapy With Tirzepatide, Empagliflozin and Pioglitazone Versus Standard Therapy in Newly Diagnosed Type 2 Diabetes: a Multi-center Randomized Controlled Trial
The goal of this clinical trial is to learn the efficacy of combination therapy with tirzepatide, empagliflozin and pioglitazone versus standard therapy in newly diagnosed type 2 diabetes. The main objectives to achieve are:
- To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM.
- To compare the effects on β-cell function and glycemic control of the triple combination therapy against standard therapy in patients newly diagnosed with T2DM Researchers will compare drug new triple combination therapy with tirzepatide, empagliflozin, and pioglitazone to standard therapy (metformin based treatment) to see if new triple combination therapy works better in achieving type 2 diabetes remission.
Participants will:
- Take new triple combination therapy or a standard therapy every day for 6 months
- Visit the clinic once every 0.5-1 month for checkups and tests
- Keep a diary of their fingertip blood glucose and adverse events
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Hai Li, MD, PHD
- 전화번호: +86-15920362668
- 이메일: lihai8@mail.sysu.edu.cn
연구 장소
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510080
- The First Affiliated Hospital of Sun Yat-sen University
-
연락하다:
- Hai Li, MD, PHD
- 전화번호: +86-15920362668
- 이메일: lihai8@mail.sysu.edu.cn
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male or female, 18 years≤age≤75 years at the time of signing informed consent.
- Newly diagnosed with type 2 diabetes, or diagnosed within 1 years according to the WHO diagnostic criteria.
- Individuals who had not received previous antidiabetic therapy, or had not received antidiabetic therapy within 3 months prior to screening, or had not received antidiabetic therapy for more than 3 consecutive months or a combined total of more than 3 months in the past 2 years.
- 6.5%≤HbA1c≤9.0% at screening confirmed by central laboratory analysis.
- BMI≥24 kg/m2.
Exclusion Criteria:
- Individuals with type 1 diabetes or special types of diabetes.
- Allergy or intolerance to investigational drugs.
- Estimated Glomerular Filtration Rate (eGFR) <20 mL/min/1.73 m².
- Individuals with heart failure in New York Heart Association [NYHA] class III or IV in the 6 months prior to randomization.
- History of bladder cancer or hematuria.
- History of Multiple Endocrine Neoplasia Type 2 (MEN 2) or relevant family history.
- History or family history of Medullary Thyroid Carcinoma (MTC), or susceptibility to MTC due to hereditary conditions.
- History of fasting blood glucose≥13.9 mmol/L or the necessity for insulin use due to severe infection, diabetic foot, etc.
- History of acute diabetic complications: including diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis.
- Severe diabetic microvascular complications: proliferative retinopathy, or urinary AER>300mg/g, or urinary protein positive, quantitative >0.5g/24h.
- Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy.
- Severe diabetic macrovascular complications: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack and/or peripheral arterial disease required for vascular intervention or amputation within the 12 months prior to screening.
- Blood pressure persistently higher than 180/110 mmHg and not controllable to ≤160/100 mmHg within 1 week.
- Alanine Aminotransferase (ALT) ≥2.5 times the upper normal limit, total bilirubin ≥1.5 times the upper normal limit.
- Hemoglobin <100g/L or requiring regular blood transfusion.
- Use of medicines potentially affecting blood glucose for more than 1 week cumulatively in the past 12 weeks, such as corticosteroids, growth hormone analogs, estrogen/progestogen, high-dose diuretics, antipsychotic drugs, etc.
- Participation in another trial involving medicine therapy within the past 3 months.
- Expected lifespan less than 2 years as per the investigator's clinical judgment, e.g., but not limited to malignancy.
- Pregnant or lactating females, or females of childbearing potential who cannot or are unwilling to use adequate contraception.
- Deemed unsuitable for participation in this clinical trial at the discretion of the investigator.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group A (triple combination intensive therapy group)
Tirzepatide, empagliflozin, and pioglitazone treatment.
1) Initiate with Tirzepatide 2.5 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, adjust Tirzepatide to 5.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 3) After 1 month, adjust Tirzepatide to 7.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd.
4) After 1 month, adjust Tirzepatide to 10.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 5) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.
|
1) Initiate with Tirzepatide 2.5 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, adjust Tirzepatide to 5.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 3) After 1 month, adjust Tirzepatide to 7.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd.
4) After 1 month, adjust Tirzepatide to 10.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 5) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.
|
|
활성 비교기: Group B (standard therapy group)
Metformin-based treatment is recommended when not contraindicated.
1) Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After 1 month, if blood glucose remains uncontrolled, add Tirzepatide 2.5 mg qw; 4) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 5.0 mg qw; 5) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 7.5 mg qw; 6) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 10.0 mg qw.
|
1) Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After 1 month, if blood glucose remains uncontrolled, add Tirzepatide 2.5 mg qw; 4) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 5.0 mg qw; 5) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 7.5 mg qw; 6) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 10.0 mg qw.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
당뇨병 완화율
기간: 약물 중단 후 6 개월
|
약물 중단 후 6 개월의 당뇨병 완화율 (HBA1C 환자의 백분율 <6.5% 약물 중단 후 6 개월)
|
약물 중단 후 6 개월
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
당뇨병 완화율
기간: 약물 중단 후 3 및 12 개월
|
약물 중단 후 3 개월 및 12 개월의 당뇨병 완화율 및 당뇨병 완화 시간
|
약물 중단 후 3 및 12 개월
|
|
EQ-5D-5L 설문지, 삶의 질
기간: 기준선, 약물 치료 6 개월 및 약물 중단 후 3, 6 및 12 개월에
|
EQ-5D-5L 설문지, 삶의 질 평가. EQ-5D-5L은 본질적으로 2 페이지 : EQ-5D 설명 시스템 및 EQ 시각적 아날로그 척도 (EQ VAS)로 구성됩니다. 설명 시스템은 이동성, 자기 관리, 일반적인 활동, 통증/불편 및 불안/우울증의 5 가지 차원으로 구성됩니다. 각 차원에는 문제 없음, 약간의 문제, 중간 정도의 문제, 심각한 문제 및 극한 문제의 5 가지 수준이 있습니다. EQ VAS는 환자의 자체 등급 건강을 수직 시각적 아날로그 척도로 기록하며 엔드 포인트에는 '상상할 수있는 최고의 건강'과 '상상할 수있는 최악의 건강'이 표시됩니다. VAS는 환자 자신의 판단을 반영하는 건강 결과의 정량적 척도로 사용될 수 있습니다. |
기준선, 약물 치료 6 개월 및 약물 중단 후 3, 6 및 12 개월에
|
|
추가 완화 당 증분 비용
기간: 약물 중단 후 6 개월
|
약물 중단 후 6 개월에 추가 완화 당 증분 비용
|
약물 중단 후 6 개월
|
|
범위 내 시간 (TIR)
기간: 기준선, 약물 치료 6 개월 및 약물 중단 후 6 개월에
|
목표 혈당 범위 내에서의 시간 (3.9-10.0
MMOL/L)
|
기준선, 약물 치료 6 개월 및 약물 중단 후 6 개월에
|
|
범위 (TIR)의 추가 개선 시간당 증분 비용
기간: 약물 치료 6 개월 및 약물 중단 후 6 개월
|
약물 치료 6 개월 및 약물 중단 후 6 개월에 범위 (TIR)의 추가 개선 시간당 증분 비용
|
약물 치료 6 개월 및 약물 중단 후 6 개월
|
|
Time required to achieve glycemic goal
기간: 6 months of medication
|
The time required to achieve glycemic goal(FBG <6.1mmol/L, 2h PPG <8.0mmol/L or HbA1c#6.5%)
|
6 months of medication
|
|
HbA1c
기간: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
HbA1c level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Blood glucose level
기간: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
Fasting and 2-hour postprandial blood glucose level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Blood insulin level
기간: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
Fasting and 2-hour postprandial insulin level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Blood C-peptide level
기간: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
Fasting and 2-hour postprandial C-peptide level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Pancreatic β-cell function
기간: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
HOMA-B at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Insulin resistance
기간: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
HOMA-IR at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Weight changes
기간: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
Weight at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Incremental cost per QALY gained
기간: At baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
|
Incremental cost per QALY gained, derived from EQ-5D-5L assessments at baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
|
At baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R21002
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .