NCT06739122招募中3 期
A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 69
- 主要终点
- Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening.
- •Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of >85th percentile
排除标准
- •Have Type 1 diabetes
- •Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening
- •After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- •Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months
- •Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
- •Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease
- •Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening
研究组 & 干预措施
Dulaglutide
Experimental
Participants will receive dulaglutide subcutaneously (SC)
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Week 26
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide(Predose through Week 30)
- PK: Maximum Observed Concentration (Cmax) of Dulaglutide(Predose through Week 30)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 26)
- Percent Change from Baseline in Body Weight(Baseline, Week 26)
- Change from Baseline in Total Cholesterol(Baseline, Week 26)
- Change from Baseline in the EQ-5D-Y-5L(Baseline, Week 26)
- Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)(Baseline, Week 26)
研究者
研究点 (69)
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