CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 413 enrolled
Drug / intervention
BI 456906 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04153929
NCT04153929Phase 2Completed

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.

Boehringer Ingelheim·interventional·Posted Nov 6, 2019·Updated Nov 29, 2022

In Brief

A Phase 2 clinical trial evaluating BI 456906, Placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 413 participants across 80 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Canada, Czechia, Germany, Hungary, New Zealand, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartApr 30, 2020
Primary CompletionOct 8, 2021
Study CompletionNov 4, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.7 years ago

Interventions

BI 456906drug

Solution for Injection

Placebodrug

Solution for Injection

Semaglutidedrug

Solution for Injection