NCT07064486招募中3 期
A Phase 3, Randomized, Open Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 477
- 试验地点
- 4
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •○ Have been diagnosed with type 2 diabetes mellitus (T2DM);
- •Be on stable treatment with unchanged dose of metformin ≥1500 mg/day or <1500 mg/day but ≥1000 mg/day (the maximum tolerated dose) for at least 8 weeks prior to screening
- •Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
- •Be of stable weight (± 5%) for at least 3 months before screening;
- •Have HbA1c between ≥7.5% and ≤11.0% at screening
排除标准
- •○ Previous diagnosis of type 1 diabetes, special type diabetes;
- •Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy;
- •Have the acute or chronic pancreatitis;
- •Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening;
- •Have a serious mental illness or speech impediment and be unable to fully understand the study;
- •Suspected or confirmed history of alcohol or drug abuse;
- •Have had a history of ≥2 severe hypoglycemic episodes in the past 1 year;
- •Other conditions that may impact the assessment of investigational products, as determined by the Investigator.
研究组 & 干预措施
5 mg BGM0504
Experimental
5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
干预措施: BGM0504 (Drug)
10 mg BGM0504
Experimental
10 mg BGM0504 administered SC once a week.
干预措施: BGM0504 (Drug)
1 mg Semaglutide
Active Comparator
1 mg semaglutide administered SC once a week
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Week 0 to Week 24
Change from baseline in HbA1c after 24 weeks of treatment.
次要结局
- Change From Baseline in Hemoglobin A1c (HbA1c)(Week 0 to Week 12)
- Change From Baseline in Body Weight(Week 0 to Week 24)
- Percentage of Participants With HbA1c Target Value of <7%(Week 0 to Week 24)
- Percentage of Participants With HbA1c Target Value of <5.7%(Week 0 to Week 24)
- Change From Baseline in Fasting Serum Glucose(Week 0 to Week 24)
研究者
研究点 (4)
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