A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
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.
2 other identifiers
interventional
413
13 countries
74
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Apr 2020
Typical duration for phase_2 diabetes-mellitus-type-2
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedStudy Start
First participant enrolled
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2021
CompletedResults Posted
Study results publicly available
November 29, 2022
CompletedNovember 29, 2022
November 1, 2022
1.4 years
November 5, 2019
November 2, 2022
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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).
Study Arms (8)
BI 456906 0.3 mg
EXPERIMENTALBI 456906 0.9 mg
EXPERIMENTALBI 456906 1.8 mg
EXPERIMENTALBI 456906 2.7 mg
EXPERIMENTALBI 456906 1.2 twice weekly (2.4) mg
EXPERIMENTALBI 456906 1.8 twice weekly (3.6) mg
EXPERIMENTALSemaglutide
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Solution for Injection
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent in accordance with International conference on harmonization - Good clinical practice (ICH GCP) and local legislation.
- Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
- Diagnosis of Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent.
- Glycosylated hemoglobin A1c (HbA1c) 7.0%-10.0% (both inclusive) at screening.
- Treatment with a stable dose of metformin ≥ 1000mg/day for at least 3 months prior to screening.
- Body mass index (BMI) 25 kg/m2-50 kg/m2 (both inclusive) at screening.
- Women of childbearing potential must be ready and able to use highly effective methods of birth control.
You may not qualify if:
- Patients with type 1 diabetes.
- Exposure to semaglutide, or other Glucagon-like-peptide 1 receptor (GLP-1R) agonists (including combination products) within 3 months prior to screening, or any previous exposure to BI 456906.
- Any additional oral anti-hyperglycemic medication beyond metformin within 3 months prior to screening.
- Use of insulin for glycemic control within 12 months prior to screening.
- Resting Heart Rate \>100 bpm or blood pressure ≥160/95 mmHg at screening.
- A marked baseline prolongation of QT/QTc (Fridericia) interval or any other clinically significant Electrocardiogram (ECG) finding at screening.
- Body weight change of +/- 5% or more in the past 3 months or on anti-obesity therapies at any time during the 6 months prior to screening.
- Continuous oral pharmacotherapy to treat any clinical condition during the Trial. Following medications are allowed:
- metformin, anti-hypertensives (any medication known to cause heart block or bradycardia such as beta-blockers, verapamil and diltiazem are excluded unless used to treat heart rate control or hypertension),
- Hormone replacement therapy including thyroid hormone, lipid lowering, proton pump inhibitors, H2 blockers for Gastric esophageal reflux disease (GERD), analgesics,
- sleep medications
- antihistamines
- selective Alpha receptor blocker for benign prostatic hyperplasia Patients must be on a stable dose for at least 3 months Prior to Screening
- Any suicidal behavior in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-suicide severity rating scale (C-SSRS) in the past 3 months at screening.
- Chronic or relevant acute infections.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
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
St. 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
City of 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
KH Rudolfstiftung, 1. Med. Abt., Wien
Vienna, 1030, Austria
AKH - Medical University of Vienna
Vienna, 1090, 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)
Lévis, 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, 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
Balatonfüred, 8230, Hungary
Bajcsy-Zsilinszky Hospital and Clinic
Budapest, 1106, Hungary
University Debrecen Hospital
Debrecen, 4032, Hungary
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
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647, South Korea
Dongguk University Ilsan Hospital
Goyang, 10326, South Korea
Kangdong Sacred Heart Hospital
Seoul, 134701, South Korea
Hospital A Coruña
A Coruña, 15006, Spain
C.A.P. Sardenya
Barcelona, 08025, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clínico de Valencia
Valencia, 46010, Spain
Chang-Hua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 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
Related Publications (1)
Bluher M, Rosenstock J, Hoefler J, Manuel R, Hennige AM. Dose-response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial. Diabetologia. 2024 Mar;67(3):470-482. doi: 10.1007/s00125-023-06053-9. Epub 2023 Dec 14.
PMID: 38095657DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2019
First Posted
November 6, 2019
Study Start
April 30, 2020
Primary Completion
October 8, 2021
Study Completion
November 4, 2021
Last Updated
November 29, 2022
Results First Posted
November 29, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.