NCT04153929

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight. Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice every week. Some participants get different doses of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906 injections, but contain no medicine. Participants in group 7 get semaglutide injections every week. Semaglutide is another medicine for adults with type 2 diabetes. During the study, the doctors regularly take blood samples from the participants and measure their body weight. The changes in blood sugar levels and body weight are compared between the groups. The doctors also check the general health of the participants.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	BI 456906	Solution for Injection
DRUG	Placebo	Solution for Injection
DRUG	Semaglutide	Solution for Injection

Timeline

• Start date: 2020-04-30
• Primary completion: 2021-10-08
• Completion: 2021-11-04
• First posted: 2019-11-06
• Last updated: 2022-11-29
• Results posted: 2022-11-29

Locations

80 sites across 14 countries: United States, Australia, Austria, Canada, Czechia, Germany, Hungary, New Zealand, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study