EUCTR2019-002390-60-IT进行中（未招募）1 期
A Phase II, randomized, parallel group, dose-finding study of subcutaneously administered BI 456906 for 16 weeks, compared with placebo and open-label semaglutide in patients with type 2 diabetes mellitus. -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 410 人开始时间: 2020年10月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 410
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Signed and dated written informed consent in accordance with ICH GCP
- •and local legislation.
- •-Male and female patients 18 years to 75 years (both inclusive) of age on
- •the day of signing informed consent.
- •-Diagnosis of T2DM at least 6 months prior to informed consent.
- •HbA1c 7.0%-10.0% (both inclusive).
- •-Treatment with a stable dose of metformin >= 1000mg/day for at least 3
- •months prior to screening.
- •-Body mass index (BMI) 25 kg/m2-50 kg/m2 (both inclusive) at
- •-Women of childbearing potential and men able to father a child must be
- •ready and able to use highly effective methods of birth control.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Patients with type 1 diabetes.
- •Exposure to semaglutide, or other GLP-1R agonists (including
- •combination products) within 3 months prior to screening, or any
- •previous exposure to BI 456906.
- •Any additional oral anti-hyperglycemic medication beyond metformin
- •within 3 months prior to screening.
- •Use of insulin for glycemic control within 12 months prior to screening.
- •Resting Heart Rate >100 bpm or supine blood pressure =160/95 mmHg
- •at screening.
- •A marked baseline prolongation of QT/QTc interval or any other clinically
- •significant ECG finding at screening.
- •Body weight change of +/- 5% in the past 3 months or on anti-obesity
- •therapies at any time during the 6 months prior to randomization.
- •Treatment for any clinical condition that requires continuous oral
- •pharmacotherapy during the trial except for metformin, antihypertensives,
- •thyroid hormone replacement, lipid lowering, proton
- •pump inhibitors, H2 blockers for GERD, analgesics, and inhaled
- •respiratory medications, with a stable dose for at least 3 months prior to
- •Any suicidal behavior in the past 2 years, any suicidal ideation of type 4
- •or 5 in the C-SSRS in the past 3 months at screening.
- •Chronic or relevant acute infections.
- •Women who are pregnant, nursing, or who plan to become pregnant
- •while in the trial.
- •Further criteria apply.
研究者
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