A study to test whether different doses of BI 456906 are effective in treating adults with type 2 diabetes.
- Conditions
- type 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2019-002390-60-IT
- Lead Sponsor
- BOEHRINGER-INGELHEIM ITALIA S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 410
-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
screening.
-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
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
screening.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method