EUCTR2019-002390-60-CZ进行中（未招募）1 期
A Phase II, randomized, parallel group, dose-finding study ofsubcutaneously administered BI 456906 for 16 weeks, comparedwith placebo and open-label semaglutide in patients with type 2diabetes mellitus.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •1. Signed and dated written informed consent in accordance with ICH
- •GCP and local legislation.
- •2. Male and female patients 18 years to 75 years (both inclusive) of age
- •on the day of signing informed consent.
- •3. Diagnosis of T2DM at least 6 months prior to informed consent.
- •4. HbA1c 7.0%-10.0% (both inclusive) at screening.
- •5. Treatment with a stable dose of metformin = 1000mg/day for at
- •least 3 months prior to screening.
- •6. Body mass index (BMI) 25 kg/m2-50 kg/m2 (both inclusive) at
- •7. Women of childbearing potential 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
- •1. Patients with type 1 diabetes.
- •2. Exposure to semaglutide, or other GLP-1R agonists (including
- •combination products) within 3 months prior to screening, or any
- •previous exposure to BI 456906.
- •3. Any additional oral anti-hyperglycemic medication beyond metformin
- •within 3 months prior to screening.
- •4. Use of insulin for glycemic control within 12 months prior to
- •5. Resting Heart Rate >100 bpm or blood pressure =160/95 mm Hg at
- •6. A marked prolongation of QT/QTc (Fridericia) interval or any other
- •clinically significant ECG finding at screening.
- •7. Body weight change of +/- 5% or more in the past 3 months or on
- •anti-obesity therapies at any time during the 6 months prior to
- •8. Continuous oral pharmacotherapy to treat any clinical condition
- •during the trial except for metformin, anti-hypertensives, hormone
- •replacement therapy including thyroid hormone, lipid lowering, proton
- •pump inhibitors, H2 blockers for GERD, analgesics, sleep medications,
- •antihistamines and selective alpha receptor blocker for benign prostatic
- •hyperplasia. Patients must be on a stable dose for at least 3 months
- •prior to screening.
- •9. 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.
- •10. Chronic or relevant acute infections.
- •11. 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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