2022-500101-41-00已完成4 期
A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 23
- 主要终点
- Change from baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
To demonstrate that switching from once weekly dulaglutide to once weekly tirzepatide is superior to continuing and escalating dulaglutide for HbA1c change from baseline to Week 40
研究设计
- 分配方式
- Randomized
- 主要目的
- Parallel Assignment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Have type 2 diabetes
- •Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
- •Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening
- •No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, SGLT-2i, and/or sulfonylurea, for at least 3 months before screening
- •Have stable body weight (±5%) during the 90 days preceding screening
- •Have BMI ≥25 kilogram/square meter (kg/m²)
排除标准
- •Have type 1 diabetes
- •Have been treated with 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.
- •Have a history of chronic or acute pancreatitis
- •Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or Nonproliferative diabetic retinopathy requiring acute treatment
- •Have NYHA Functional Classification Class IV CHF
- •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)
- •Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation
- •Have any of these cardiovascular conditions within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization due to congestive heart failure (CHF)
结局指标
主要结局
Change from baseline in Hemoglobin A1c (HbA1c)
Change from baseline in Hemoglobin A1c (HbA1c)
次要结局
- Change from Baseline in Weight
- Percentage of Participants Who Achieve HbA1c <7%
- Percentage of Participants Who Achieve HbA1c ≤6.5%
- Percentage of Participants Who Achieve HbA1c <5.7%
- Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%
- Percentage of Participants Who Achieve Weight loss from Baseline of ≥10%
- Percentage of Participants Who Achieve Weight loss from Baseline of ≥15%
- A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia A composite endpoint defined as HbA1c ≤6.5%, weight loss ≥10%, and no hypoglycemia, defined as blood glucose <54 milligram/deciliter (mg/dL) (<3.0 millimole/liter [mmol/L]) and/or severe hypoglycemia
- Change from Baseline in Fasting Serum Glucose
- Change from Baseline in Waist Circumference
- Change from Baseline in Body Mass Index (BMI)
- Change from Baseline in Impact of Weight on Quality of Life-Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Score
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly Cork Limited
研究点 (23)
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