jRCT2031260316招募中不适用
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes (J2A-MC-GZGY)
未提供0 个研究点目标入组 170 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 10age old over 至 18age old not（—）
- 性别
- All
入选标准
- •Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin
- •Have HbA1c > 6.5% to <= 11.0% at screening
- •Have a body weight >=50 kilograms (kg) (110 pounds) and a body mass index (BMI) of >85th percentile
排除标准
- •Have type 1 diabetes
- •After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- •Have had at least one episode of severe hypoglycemia and/or at least one episode of hypoglycemic unawareness within the last 6 months before screening
- •Have a history of pancreatitis or gallbladder disease
- •Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
- •Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening
- •Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening
研究者
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