A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT04153929
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 413
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 456906 1.8 mg BI 456906 - BI 456906 0.3 mg BI 456906 - BI 456906 0.9 mg BI 456906 - BI 456906 2.7 mg BI 456906 - BI 456906 1.2 twice weekly (2.4) mg BI 456906 - BI 456906 1.8 twice weekly (3.6) mg BI 456906 - Placebo Placebo - Semaglutide Semaglutide -
- Primary Outcome Measures
Name Time Method Absolute Change in HbA1c From Baseline to 16 Weeks 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 Outcome Measures
Name Time Method 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 relative change in body weight from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17.
The relative change in body weight from baseline to 16 weeks after treatment start was calculated as (body weight at Week 17 - body weight at baseline/body weight at baseline) \* 100.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 body weight from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.
The absolute change in body weight from baseline to 16 weeks after treatment start was calculated as: body weight at Week 17- body weight at baseline.The Absolute Change in Waist Circumference 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 after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.
The absolute change in waist circumference from baseline to 16 weeks after treatment start was calculated as: waist circumference at Week 17- waist circumference at baseline.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). The percentage of patients with 5 percent (%) or greater body weight loss from baseline to 16 weeks after treatment start is presented.
Measurements for this outcome were performed at baseline and at Week 17.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). The percentage of patients with 10 % or greater body weight loss from baseline to 16 weeks after treatment start is presented.
Measurements for this outcome were performed at baseline and at Week 17.
Trial Locations
- Locations (77)
National Research Institute
🇺🇸Los Angeles, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
In-Quest Medical Research, LLC
🇺🇸Suwanee, Georgia, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
DuPage Medical Group, Ltd
🇺🇸Lombard, Illinois, United States
Scroll for more (67 remaining)National Research Institute🇺🇸Los Angeles, California, United States