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 España, S.A.0 个研究点目标入组 410 人开始时间: 2019年11月11日最近更新: 2020年9月28日

研究概览

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•1. Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
•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).
•5. Treatment with a stable dose of metformin = 1000mg/day for at least 3 months prior to screening.
•6. Body Mass Index (BMI) 25kg/m2-50 kg/m2 (both inclusive) at screening.
•7. 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

•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-hypergylcemic medication beyond metformin within the 3 months prior to screening.
•4. Use of insulin for glycemic control within 12 months prior to screening.
•5. Resting Heart Rate >100 beats per minute (bpm) or supine blood pressure =160/95 mmHg at screening.
•6. A marked baseline prolongation of QT/QTc interval or any other clinically significant ECG finding at screening.
•7. 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.
•8. Treatment for any clinical condition that requires continuous oral pharmacotheraphy during the trial except for metformin, anti-hypertensives, 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 monts 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.

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