NL-OMON54032招募中3 期
Efficacy and safety of oral semaglutide versus placebo both in combination with metformin and/or basal insulin in children and adolescents with type 2 diabetes - PIONEER TEENS
ovo Nordisk0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
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
- 2 至 17（—）
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 less than18 years at the day of randomisation.
- •- Glycosylated haemoglobin (HbA1c) 6.5*11.0 percent (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**
- •*stable metformin dose is defined as at least 1000 mg daily or the maximum
- •tolerated dose for 56 days or longer prior to screening.
- •**stable dose of basal insulin is defined as basal insulin treatment more than
- •or equal to 30 days prior to screening, compared to the dose at screening, dose
- •adjustments of plus or minus 25 percent are allowed.
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.
- •-C-peptide <0.6 ng/mL and ALT >=3 times the UNL and bilirubin >=1.5 times the UNL
研究者
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