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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 36
- 主要终点
- Change From Baseline in HbA1c
研究概览
简要总结
The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.
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 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, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening.
- •Have had 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 a history of chronic or acute pancreatitis
- •Have a history of
- •proliferative diabetic retinopathy, or
- •diabetic maculopathy, or
- •nonproliferative diabetic retinopathy that requires acute treatment.
- •Have any of these cardiovascular (CV) conditions within 60 days prior to screening:
- •acute myocardial infarction,
- •cerebrovascular accident (stroke), or
- •hospitalization due to congestive heart failure (CHF).
- •Have New York Heart Assocation (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 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 reduction of dose of dulaglutide, due to intolerability, without successful reescalation
研究组 & 干预措施
15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)
Participants received tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5mg to 15 mg) until 15 mg or MTD was reached.
干预措施: Tirzepatide (Drug)
4.5 mg Dulaglutide or MTD
Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Change From Baseline in HbA1c
时间窗: Baseline, Week 40
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
次要结局
- Change From Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants Who Achieved HbA1c <7%(Week 40)
- Percentage of Participants Who Achieved HbA1c <=6.5%(Week 40)
- Percentage of Participants Who Achieved HbA1c <5.7%(Week 40)
- Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%(Week 40)
- Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%(Week 40)
- Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%(Week 40)
- Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)(Week 40)
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 40)
- Change From Baseline in Waist Circumference(Baseline, Week 40)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 40)
- Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score(Baseline, Week 40)