NCT05433584进行中（未招募）4 期
A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 780
- 试验地点
- 90
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
- •Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.
- •Have been on a stable treatment of metformin only at least 90 days preceding baseline
- •with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
- •<1500 mg/day in case of intolerance of full therapeutic dose.
排除标准
- •Have type 1 diabetes mellitus
- •Have a history of chronic or acute pancreatitis any time prior to study entry
- •Have a history of
- •proliferative diabetic retinopathy
- •diabetic macular edema, or
- •no proliferative diabetic retinopathy requiring immediate or urgent treatment
- •Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry
- •myocardial infarction
- •percutaneous coronary revascularization procedure
- •carotid stenting or surgical revascularization
- •nontraumatic amputation
- •peripheral vascular procedure (e.g., stenting or surgical revascularization)
- •cerebrovascular accident (stroke), or congestive heart failure
- •Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
- •Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
- •Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
- •Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.
- •Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.
研究组 & 干预措施
Tirzepatide
Experimental
Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
干预措施: Tirzepatide (Drug)
Intensified Conventional Care Dose
Active Comparator
Participants will receive an antihyperglycemic medication
干预措施: Antihyperglycemic medication (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 104
次要结局
- Percentage of Participants Achieving HbA1c <7.0%(Week 208)
- Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)](Baseline through Week 208)
- Change from Baseline in HbA1c(Baseline, Week 208)
- Change from Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 104)
- A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia(Week 208)
- Change from Baseline in β-cell Glucose Sensitivity(Baseline, Week 104)
- Change from Baseline in Weight(Baseline, Week 208)
- Change from Baseline in Waist Circumference(Baseline, Week 208)
- Change from Baseline in FSG(Baseline, Week 208)
- Percentage of Participants Achieving HbA1c <5.7%(Week 208)
- Change from Baseline in Weight loss of ≥5%,(Baseline, Week 104)
- Change from Baseline in Postprandial Insulin Sensitivity Indices(Baseline, Week 208)
- Change from Baseline in Lipids(Baseline, Week 208)
- Change from Baseline in Weight loss of ≥15%(Baseline, Week 208)
- Change from Baseline in Weight loss of ≥5%(Baseline, Week 208)
- Change from Baseline in β-cell glucose sensitivity(Baseline, Week 208)
- Percentage of Participants Achieving HbA1c ≤6.5%(Week 208)
- Change from Baseline in Weight loss of ≥10%(Baseline, Week 208)
- Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain(Baseline, Week 208)
- Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration(Baseline, Week 208)
- Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)](Baseline through Week 104)
- Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain(Baseline, Week 104)
研究者
研究点 (90)
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