A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of XW003 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)
详细描述
In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures
- •Sex: male or female; Age: 18 to 75 years, inclusive
- •BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive
- •Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening.
- •HbA1c ranging from 7.5% to 11.0% at screening, inclusive
- •FPG ≤13.9 mmol/L at screening
排除标准
- •History of type 1 or other types of diabetes mellitus
- •Use of insulin during the 6 months preceding screening
- •History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.
- •History of acute or chronic pancreatitis or high-risk factors for pancreatitis
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- •History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
- •History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
研究组 & 干预措施
B1: XW003+MET
High dosage of XW003 once weekly
干预措施: Ecnoglutide high dosage (Drug)
B1: XW003+MET
High dosage of XW003 once weekly
干预措施: Metformin (Drug)
B2: XW003+MET
Low dosage of XW003 once weekly
干预措施: Ecnoglutide low dosage (Drug)
B2: XW003+MET
Low dosage of XW003 once weekly
干预措施: Metformin (Drug)
B3: Dulaglutide+MET
1.5mg Dulaglutide once weekly
干预措施: Dulaglutide (Drug)
B3: Dulaglutide+MET
1.5mg Dulaglutide once weekly
干预措施: Metformin (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Baseline, week 32
次要结局
- Change from baseline in lipid panel(Baseline, Week 32 and Week 52)
- Change from baseline in fasting plasma glucose (FPG)(Baseline, Week 32 and Week 52)
- Change from baseline in HbA1c(Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52)
- Change from baseline in body weight(Baseline, Week 32 and Week 52)
- Pharmacokinetics: plasma trough level of XW003(Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399)