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-HU
• 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: 2019-11-26
• Study Completion: 2021-11-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 669

Inclusion Criteria

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

Exclusion Criteria

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, 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 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