A study to test whether different doses of BI 456906 are effective in treating adults with type 2 diabetes

Phase 1

• Conditions: type 2 diabetes mellitus; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-002390-60-CZ
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-28
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

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
screening.
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

Exclusion Criteria

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
screening.
5. Resting Heart Rate >100 bpm or blood pressure =160/95 mm Hg at
screening.
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
screening.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified