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.

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: BI 456906; Drug: Semaglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2006
      • Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders
    • Merewether, New South Wales, Australia, 2291
      • Hunter Diabetes Centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Monash University
    • Heidelberg, Victoria, Australia, 3081
      • Austin Health
    • Melbourne, Victoria, Australia, 3004
      • Baker Heart and Diabetes Institute
• Austria
  • Vienna, Austria, 1090
    • AKH - Medical University of Vienna
  • Wien, Austria, 1030
    • KH Rudolfstiftung, 1. Med. Abt., Wien
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 4A1
      • Cook Street Medical Clinic
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • LMC Clinical Research Inc. (Brampton)
    • Concord, Ontario, Canada, L4K 4M2
      • LMC Clinical Research Inc. (Thornhill)
    • Hamilton, Ontario, Canada, L8L 5G8
      • The Wharton Medical Clinic Clinical Trials Inc.
    • Woodstock, Ontario, Canada, N4S 5P5
      • Devonshire Clinical Research Inc.
  • Quebec
    • Levis, Quebec, Canada, G6W 0M5
      • Manna Research (Quebec)
    • Montreal, Quebec, Canada, H4N 2W2
      • Centre Medical Acadie
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Manna Research (Montreal)
• Czechia
  • Broumov, Czechia, 55001
    • Edumed s.r.o
  • Prague 2, Czechia, 128 08
    • General Faculty Hospital, Prague
• Germany
  • Aschaffenburg, Germany, 63739
    • Studienzentrum Aschaffenburg
  • Essen, Germany, 45136
    • InnoDiab Forschung Gmbh
  • Münster, Germany, 48145
    • Institut für Diabetesforschung Münster GmbH
• Hungary
  • Balatonfured, Hungary, 8230
    • DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Hospital and Clinic
  • Debrecen, Hungary, 4032
    • University Debrecen Hospital
• Korea, Republic of
  • Bucheon, Korea, Republic of, 14647
    • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Goyang, Korea, Republic of, 10326
    • Dongguk University Ilsan Hospital
  • Seoul, Korea, Republic of, 134701
    • Kangdong Sacred Heart Hospital
• New Zealand
  • Auckland, New Zealand, 1010
    • Optimal Clinical Trials
  • Newtown Wellington NZ, New Zealand, 6021
    • P3 Research
  • Paraparaumu, New Zealand, 5032
    • P3 Research Kapiti
  • Tauranga, New Zealand, 3110
    • P3 Research
• Poland
  • Bydgoszcz, Poland, 85-048
    • In-Vivo Sp. z o.o.
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Skorzewo, Poland, 60-185
    • Pratia SA
  • Torun, Poland, 87-100
    • Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
  • Warsaw, Poland, 00-465
    • Nbr Polska
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC
• Spain
  • A Coruña, Spain, 15006
    • Hospital A Coruña
  • Barcelona, Spain, 08025
    • C.A.P. Sardenya
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
• Taiwan
  • Changhua, Taiwan, 500
    • Chang-Hua Christian Hospital
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
• United Kingdom
  • Blackpool, United Kingdom, FY4 3AD
    • Waterloo Medical Centre
  • Burbage, Hinkley, United Kingdom, LE10 2SE
    • Burbage Surgery
  • Faringdon, United Kingdom, SN7 7YU
    • White Horse Medical Practice
  • Rotherham, United Kingdom, S65 1DA
    • Clifton Medical Centre, Rotherham
  • Southampton, United Kingdom, SO30 3JB
    • Moorgreen Hospital
• United States
  • California
    • Huntington Park, California, United States, 90255
      • National Research Institute
    • Los Angeles, California, United States, 90057
      • National Research Institute
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center
    • Lakeland, Florida, United States, 33803
      • Meridien Research
    • Miami, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Ocoee, Florida, United States, 34761
      • Sensible HealthCare, LLC
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
  • Georgia
    • Suwanee, Georgia, United States, 30024
      • In-Quest Medical Research, LLC
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Illinois
    • Lombard, Illinois, United States, 60148
      • DuPage Medical Group, Ltd
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research, LLC
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • The University of North Carolina at Chapel Hill
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc.
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
    • Statesville, North Carolina, United States, 28625
      • PMG Research of Piedmont Healthcare
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research, LLC
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group
  • Tennessee
    • Knoxville, Tennessee, United States, 37938
      • PMG Research of Knoxville
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes and Endocrine Center
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC
    • Sugar Land, Texas, United States, 77478
      • Javara Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Solution for Injection
Experimental: BI 456906 0.3 mg	Drug: BI 456906; Solution for Injection
Experimental: BI 456906 0.9 mg	Drug: BI 456906; Solution for Injection
Experimental: BI 456906 1.8 mg	Drug: BI 456906; Solution for Injection
Experimental: BI 456906 2.7 mg	Drug: BI 456906; Solution for Injection
Experimental: BI 456906 1.2 twice weekly (2.4) mg	Drug: BI 456906; Solution for Injection
Experimental: BI 456906 1.8 twice weekly (3.6) mg	Drug: BI 456906; Solution for Injection
Active Comparator: Semaglutide	Drug: Semaglutide; Solution for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): November 4, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1404-0002; 2019-002390-60 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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'.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No