Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed and dated written informed consent in accordance with International conference on harmonization - Good clinical practice (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 Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent.
Glycosylated hemoglobin A1c (HbA1c) 7.0%-10.0% (both inclusive) at screening.
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 screening.
Women of childbearing potential must be ready and able to use highly effective methods of birth control.
You may not be if
Patients with type 1 diabetes.
Exposure to semaglutide, or other Glucagon-like-peptide 1 receptor (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 blood pressure ≥160/95 mmHg at screening.
A marked baseline prolongation of QT/QTc (Fridericia) interval or any other clinically significant Electrocardiogram (ECG) finding at screening.
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 screening.
Continuous oral pharmacotherapy to treat any clinical condition during the Trial. Following medications are allowed:
* metformin, anti-hypertensives (any medication known to cause heart block or bradycardia such as beta-blockers, verapamil and diltiazem are excluded unless used to treat heart rate control or hypertension),
* selective Alpha receptor blocker for benign prostatic hyperplasia Patients must be on a stable dose for at least 3 months Prior to Screening
Any suicidal behavior in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-suicide severity rating scale (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.
