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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 413
- Locations
- 77
- Primary Endpoint
- Absolute Change in HbA1c From Baseline to 16 Weeks
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The trial has a double blind design within each dose group. Patients, investigators and everyone involved in trial conduct or analysis or with any other interest in this trial will remain blinded with regard to the randomized treatment assignments until after database lock. The semaglutide group is open label.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 456906 0.3 mg
Intervention: BI 456906 (Drug)
BI 456906 0.9 mg
Intervention: BI 456906 (Drug)
BI 456906 1.8 mg
Intervention: BI 456906 (Drug)
BI 456906 2.7 mg
Intervention: BI 456906 (Drug)
BI 456906 1.2 twice weekly (2.4) mg
Intervention: BI 456906 (Drug)
BI 456906 1.8 twice weekly (3.6) mg
Intervention: BI 456906 (Drug)
Semaglutide
Intervention: Semaglutide (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Absolute Change in HbA1c From Baseline to 16 Weeks
Time Frame: At baseline and at Week 17 (16 weeks after treatment start).
Absolute change in glycosylated hemoglobin A1c (HbA1c) from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17. Absolute change from baseline in HbA1c to 16 weeks after treatment start was calculated by subtracting the baseline HbA1c value from the HbA1c value at Week 17.
Secondary Outcomes
- Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks(At baseline and at Week 17 (16 weeks after treatment start ).)
- The Absolute Change in Body Weight From Baseline to 16 Weeks(At baseline and at Week 17 (16 weeks after treatment start).)
- The Absolute Change in Waist Circumference From Baseline to 16 Weeks(At baseline and at Week 17 (16 weeks after treatment start).)
- Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks(At baseline and at Week 17 (16 weeks after treatment start).)
- Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks(At baseline and at Week 17 (16 weeks after treatment start).)