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Diabetes Mellitus, Type 2Phase 2NCT04153929

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

A Phase 2 study testing BI 456906 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 80 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
BI 456906 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
413 participants
Where
80 sitesin 14 countries
Study dates
30 Apr 2020to 4 Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

80 sites in 14 countries.

80 sites in 14 countries

United States31 sites

  • Heritage Valley Medical Group

    Beaver, Pennsylvania, 15009

  • Mercury Street Medical

    Butte, Montana, 59701

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303

  • Dallas Diabetes and Endocrine Center

    Dallas, Texas, 75230

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602

  • National Research Institute

    Huntington Park, California, 90255

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37938

  • Meridien Research

    Lakeland, Florida, 33803

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • DuPage Medical Group, Ltd

    Lombard, Illinois, 60148

  • National Research Institute

    Los Angeles, California, 90057

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • ActivMed Practices & Research

    Methuen, Massachusetts, 01844

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33014

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Meridien Research

    St. Petersburg, Florida, 33709

  • PMG Research of Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Javara Research

    Sugar Land, Texas, 77478

  • In-Quest Medical Research, LLC

    Suwanee, Georgia, 30024

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada8 sites

  • LMC Clinical Research Inc. (Brampton)

    Brampton, Ontario, L6S 0C6

  • LMC Clinical Research Inc. (Thornhill)

    Concord, Ontario, L4K 4M2

  • The Wharton Medical Clinic Clinical Trials Inc.

    Hamilton, Ontario, L8L 5G8

  • Manna Research (Quebec)

    Lévis, Quebec, G6W 0M5

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Manna Research (Montreal)

    Pointe-Claire, Quebec, H9R 4S3

  • Cook Street Medical Clinic

    Victoria, British Columbia, V8V 4A1

  • Devonshire Clinical Research Inc.

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash University

    Box Hill, Victoria, 3128

  • Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders

    Camperdown, New South Wales, 2006

  • Austin Health

    Heidelberg, Victoria, 3081

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

Other trials in Australia

Poland5 sites

  • In-Vivo Sp. Z o.o.

    Bydgoszcz, 85-048

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Pratia SA

    Skorzewo, 60-185

  • Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun

    Torun, 87-100

  • NBR Polska

    Warsaw, 00-465

Other trials in Poland

United Kingdom5 sites

  • Waterloo Medical Centre

    Blackpool, FY4 3AD

  • Burbage Surgery

    Burbage, Hinkley, LE10 2SE

  • White Horse Medical Practice

    Faringdon, SN7 7YU

  • Clifton Medical Centre, Rotherham

    Rotherham, S65 1DA

  • Moorgreen Hospital

    Southampton, SO30 3JB

Other trials in United Kingdom

New Zealand4 sites

  • Optimal Clinical Trials

    Auckland, 1010

  • P3 Research

    Newtown Wellington NZ, 6021

  • P3 Research Kapiti

    Paraparaumu, 5032

  • P3 Research

    Tauranga, 3110

Other trials in New Zealand

Spain4 sites

  • Hospital A Coruña

    A Coruña, 15006

  • C.A.P. Sardenya

    Barcelona, 08025

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Germany3 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Institut für Diabetesforschung Münster GmbH

    Münster, 48145

Other trials in Germany

Hungary3 sites

  • DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured

    Balatonfüred, 8230

  • Bajcsy-Zsilinszky Hospital and Clinic

    Budapest, 1106

  • University Debrecen Hospital

    Debrecen, 4032

Other trials in Hungary

South Korea3 sites

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon-si, 14647

  • Dongguk University Ilsan Hospital

    Goyang, 10326

  • Kangdong Sacred Heart Hospital

    Seoul, 134701

Other trials in South Korea

Taiwan3 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chung Shan Medical University Hospital

    Taichung, 40201

Other trials in Taiwan

Austria2 sites

  • KH Rudolfstiftung, 1. Med. Abt., Wien

    Vienna, 1030

  • AKH - Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Czechia2 sites

  • Edumed s.r.o

    Broumov, 55001

  • General Faculty Hospital, Prague

    Prague, 128 08

Other trials in Czechia

Puerto Rico1 site

  • GCM Medical Group, PSC

    San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
BI 456906, Placebo, Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 456906Drug

    Solution for Injection

  • PlaceboDrug

    Solution for Injection

  • SemaglutideDrug

    Solution for Injection

Study groups in NCT04153929
Study groupRoleWhat they receive
BI 456906 0.3 mgExperimentalNot described
Receives: Drug: BI 456906
BI 456906 0.9 mgExperimentalNot described
Receives: Drug: BI 456906
BI 456906 1.8 mgExperimentalNot described
Receives: Drug: BI 456906
BI 456906 2.7 mgExperimentalNot described
Receives: Drug: BI 456906
BI 456906 1.2 twice weekly (2.4) mgExperimentalNot described
Receives: Drug: BI 456906
BI 456906 1.8 twice weekly (3.6) mgExperimentalNot described
Receives: Drug: BI 456906
SemaglutideActive comparatorNot described
Receives: Drug: Semaglutide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline and at Week 17 (16 weeks after treatment start).

Secondary outcomes (5)

  1. 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.

    Measured: At baseline and at Week 17 (16 weeks after treatment start ).

  2. 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.

    Measured: At baseline and at Week 17 (16 weeks after treatment start).

  3. 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.

    Measured: At baseline and at Week 17 (16 weeks after treatment start).

  4. 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.

    Measured: At baseline and at Week 17 (16 weeks after treatment start).

  5. 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.

    Measured: At baseline and at Week 17 (16 weeks after treatment start).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start30 Apr 2020
  3. Primary completion8 Oct 2021
  4. Study completion4 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04153929
Sponsor's protocol ID
1404-0002
Other IDs
2019-002390-60, 2019
Status last verified
Nov 2022
First submitted
5 Nov 2019
Last updated
29 Nov 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Ekinci EI, Maldonado SG, Unseld A, Martinez JA, Hennige AM, Schoelch C. Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity. Diabetes Obes Metab. 2026 Sep;28(9):8242-8253. doi: 10.1111/dom.70861. Epub 2026 Jun 22.

    PubMed 42331726

  • 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.

    PubMed 38095657

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 456906 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 80 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Canada, Australia, Poland, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in HbA1c From Baseline to 16 Weeks (time frame: At baseline and at Week 17 (16 weeks after treatment start).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04153929, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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