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Clinical Trial Details

Trial ID: L2529
Source ID: NCT04153929
Associated Drug: Bi 456906
Title: A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04153929/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 456906|DRUG: Placebo|DRUG: Semaglutide
Outcome Measures: Primary: Absolute Change in HbA1c From Baseline to 16 Weeks, 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., At baseline and at Week 17 (16 weeks after treatment start). | Secondary: Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks, 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., At baseline and at Week 17 (16 weeks after treatment start ).|The Absolute Change in Body Weight From Baseline to 16 Weeks, 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., At baseline and at Week 17 (16 weeks after treatment start).|The Absolute Change in Waist Circumference From Baseline to 16 Weeks, 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., 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, 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., 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, 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., At baseline and at Week 17 (16 weeks after treatment start).
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 413
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-04-30
Completion Date: 2021-11-04
Results First Posted: 2022-11-29
Last Update Posted: 2022-11-29
Locations: National Research Institute, Huntington Park, California, 90255, United States|National Research Institute, Los Angeles, California, 90057, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Indago Research and Health Center, Hialeah, Florida, 33012, United States|Meridien Research, Lakeland, Florida, 33803, United States|San Marcus Research Clinic, Inc., Miami, Florida, 33014, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|Sensible Healthcare, LLC, Ocoee, Florida, 34761, United States|Meridien Research, Saint Petersburg, Florida, 33709, United States|In-Quest Medical Research, LLC, Suwanee, Georgia, 30024, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|DuPage Medical Group, Ltd, Lombard, Illinois, 60148, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|ActivMed Practices & Research, Methuen, Massachusetts, 01844, United States|StudyMetrix Research, LLC, Saint Peters, Missouri, 63303, United States|Mercury Street Medical, Butte, Montana, 59701, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States|PMG Research of Hickory, LLC, Hickory, North Carolina, 28602, United States|Lucas Research, Inc., Morehead City, North Carolina, 28557, United States|PMG Research of Raleigh, LLC, Raleigh, North Carolina, 27609, United States|PMG Research of Piedmont Healthcare, Statesville, North Carolina, 28625, United States|PMG Research of Wilmington, LLC, Wilmington, North Carolina, 28401, United States|PMG Research of Winston-Salem, Winston-Salem, North Carolina, 27103, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States|Lillestol Research, LLC, Fargo, North Dakota, 58104, United States|Heritage Valley Medical Group, Beaver, Pennsylvania, 15009, United States|PMG Research of Knoxville, Knoxville, Tennessee, 37938, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, 75230, United States|Clinical Trials of Texas, LLC, San Antonio, Texas, 78229, United States|Javara Research, Sugar Land, Texas, 77478, United States|Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders, Camperdown, New South Wales, 2006, Australia|Hunter Diabetes Centre, Merewether, New South Wales, 2291, Australia|Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia|Monash University, Box Hill, Victoria, 3128, Australia|Austin Health, Heidelberg, Victoria, 3081, Australia|Baker Heart and Diabetes Institute, Melbourne, Victoria, 3004, Australia|AKH - Medical University of Vienna, Vienna, 1090, Austria|KH Rudolfstiftung, 1. Med. Abt., Wien, Wien, 1030, Austria|Cook Street Medical Clinic, Victoria, British Columbia, V8V 4A1, Canada|LMC Clinical Research Inc. (Brampton), Brampton, Ontario, L6S 0C6, Canada|LMC Clinical Research Inc. (Thornhill), Concord, Ontario, L4K 4M2, Canada|The Wharton Medical Clinic Clinical Trials Inc., Hamilton, Ontario, L8L 5G8, Canada|Devonshire Clinical Research Inc., Woodstock, Ontario, N4S 5P5, Canada|Manna Research (Quebec), Levis, Quebec, G6W 0M5, Canada|Centre Medical Acadie, Montreal, Quebec, H4N 2W2, Canada|Manna Research (Montreal), Pointe-Claire, Quebec, H9R 4S3, Canada|Edumed s.r.o, Broumov, 55001, Czechia|General Faculty Hospital, Prague, Prague 2, 128 08, Czechia|Studienzentrum Aschaffenburg, Aschaffenburg, 63739, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Institut für Diabetesforschung Münster GmbH, Münster, 48145, Germany|DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured, Balatonfured, 8230, Hungary|Bajcsy-Zsilinszky Hospital and Clinic, Budapest, 1106, Hungary|University Debrecen Hospital, Debrecen, 4032, Hungary|The Catholic University of Korea, Bucheon St.Mary's Hospital, Bucheon, 14647, Korea, Republic of|Dongguk University Ilsan Hospital, Goyang, 10326, Korea, Republic of|Kangdong Sacred Heart Hospital, Seoul, 134701, Korea, Republic of|Optimal Clinical Trials, Auckland, 1010, New Zealand|P3 Research, Newtown Wellington NZ, 6021, New Zealand|P3 Research Kapiti, Paraparaumu, 5032, New Zealand|P3 Research, Tauranga, 3110, New Zealand|In-Vivo Sp. Z o.o., Bydgoszcz, 85-048, Poland|Vita Longa Sp. z o.o., Katowice, 40-748, Poland|Pratia SA, Skorzewo, 60-185, Poland|Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun, Torun, 87-100, Poland|NBR Polska, Warsaw, 00-465, Poland|GCM Medical Group, PSC, San Juan, 00917, Puerto Rico|Hospital A Coruña, A Coruña, 15006, Spain|C.A.P. Sardenya, Barcelona, 08025, Spain|Hospital Virgen de la Victoria, Malaga, 29010, Spain|Hospital Clínico de Valencia, Valencia, 46010, Spain|Chang-Hua Christian Hospital, Changhua, 500, Taiwan|Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, 83301, Taiwan|Chung Shan Medical University Hospital, Taichung, 40201, Taiwan|Waterloo Medical Centre, Blackpool, FY4 3AD, United Kingdom|Burbage Surgery, Burbage, Hinkley, LE10 2SE, United Kingdom|White Horse Medical Practice, Faringdon, SN7 7YU, United Kingdom|Clifton Medical Centre, Rotherham, Rotherham, S65 1DA, United Kingdom|Moorgreen Hospital, Southampton, SO30 3JB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04153929

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress