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)
Javara Research
🇺🇸Sugar Land, Texas, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Burbage Surgery
🇬🇧Burbage, Hinkley, United Kingdom
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
In-Quest Medical Research, LLC
🇺🇸Suwanee, Georgia, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Hospital ClÃnico de Valencia
🇪🇸Valencia, Spain
AKH - Medical University of Vienna
🇦🇹Vienna, Austria
Pratia SA
🇵🇱Skorzewo, Poland
P3 Research Kapiti
🇳🇿Paraparaumu, New Zealand
White Horse Medical Practice
🇬🇧Faringdon, United Kingdom
In-Vivo Sp. Z o.o.
🇵🇱Bydgoszcz, Poland
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
🇵🇱Torun, Poland
Hospital A Coruña
🇪🇸A Coruña, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Moorgreen Hospital
🇬🇧Southampton, United Kingdom
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
Cook Street Medical Clinic
🇨🇦Victoria, British Columbia, Canada
Chang-Hua Christian Hospital
🇨🇳Changhua, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Manna Research (Montreal)
🇨🇦Pointe-Claire, Quebec, Canada
The Wharton Medical Clinic Clinical Trials Inc.
🇨🇦Hamilton, Ontario, Canada
Institut für Diabetesforschung Münster GmbH
🇩🇪Münster, Germany
General Faculty Hospital, Prague
🇨🇿Prague 2, Czechia
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
DuPage Medical Group, Ltd
🇺🇸Lombard, Illinois, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
ActivMed Practices & Research
🇺🇸Methuen, Massachusetts, United States
StudyMetrix Research, LLC
🇺🇸Saint Peters, Missouri, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Palm Research Center
🇺🇸Las Vegas, Nevada, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
PMG Research of Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Heritage Valley Medical Group
🇺🇸Beaver, Pennsylvania, United States
PMG Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders
🇦🇺Camperdown, New South Wales, Australia
Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Baker Heart and Diabetes Institute
🇦🇺Melbourne, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Monash University
🇦🇺Box Hill, Victoria, Australia
LMC Clinical Research Inc. (Brampton)
🇨🇦Brampton, Ontario, Canada
KH Rudolfstiftung, 1. Med. Abt., Wien
🇦🇹Wien, Austria
LMC Clinical Research Inc. (Thornhill)
🇨🇦Concord, Ontario, Canada
Devonshire Clinical Research Inc.
🇨🇦Woodstock, Ontario, Canada
Studienzentrum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Manna Research (Quebec)
🇨🇦Levis, Quebec, Canada
Centre Medical Acadie
🇨🇦Montreal, Quebec, Canada
Edumed s.r.o
🇨🇿Broumov, Czechia
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured
ðŸ‡ðŸ‡ºBalatonfured, Hungary
Bajcsy-Zsilinszky Hospital and Clinic
ðŸ‡ðŸ‡ºBudapest, Hungary
University Debrecen Hospital
ðŸ‡ðŸ‡ºDebrecen, Hungary
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
The Catholic University of Korea, Bucheon St.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Optimal Clinical Trials
🇳🇿Auckland, New Zealand
P3 Research
🇳🇿Tauranga, New Zealand
Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
C.A.P. Sardenya
🇪🇸Barcelona, Spain
NBR Polska
🇵🇱Warsaw, Poland
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Waterloo Medical Centre
🇬🇧Blackpool, United Kingdom
Clifton Medical Centre, Rotherham
🇬🇧Rotherham, United Kingdom
GCM Medical Group, PSC
🇵🇷San Juan, Puerto Rico