CTIS2023-506923-27-00招募中1 期
PIONEER TEENSEfficacy and safety of oral semaglutide versus placebo both in combination with metformin and/or basal insulin in children and adolescents with type 2 diabetes. - NN9924-4437
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 127
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial., Male or female, aged 10 to <18 years at the day of randomisation., HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive), Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with: stable metformin dose, or stable metformin dose and a stable dose of basal insulin, or stable dose of basal insulin
排除标准
- •Diagnosis of type 1 diabetes, Maturity onset diabetes of the young (MODY), Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
研究者
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