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

NCT ID: NCT04153929

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2021-11-04

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BI 456906 0.3 mg

Group Type: EXPERIMENTAL

BI 456906

Intervention Type: DRUG

Solution for Injection

BI 456906 0.9 mg

Group Type: EXPERIMENTAL

BI 456906

Intervention Type: DRUG

Solution for Injection

BI 456906 1.8 mg

Group Type: EXPERIMENTAL

BI 456906

Intervention Type: DRUG

Solution for Injection

BI 456906 2.7 mg

Group Type: EXPERIMENTAL

BI 456906

Intervention Type: DRUG

Solution for Injection

BI 456906 1.2 twice weekly (2.4) mg

Group Type: EXPERIMENTAL

BI 456906

Intervention Type: DRUG

Solution for Injection

BI 456906 1.8 twice weekly (3.6) mg

Group Type: EXPERIMENTAL

BI 456906

Intervention Type: DRUG

Solution for Injection

Semaglutide

Group Type: ACTIVE_COMPARATOR

Semaglutide

Intervention Type: DRUG

Solution for Injection

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution for Injection

Interventions

BI 456906

Solution for Injection

Intervention Type: DRUG

Placebo

Solution for Injection

Intervention Type: DRUG

Semaglutide

Solution for Injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Research Institute

Huntington Park, California, United States

National Research Institute

Los Angeles, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Indago Research and Health Center

Hialeah, Florida, United States

Meridien Research

Lakeland, Florida, United States

San Marcus Research Clinic, Inc.

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Sensible Healthcare, LLC

Ocoee, Florida, United States

Meridien Research

St. Petersburg, Florida, United States

In-Quest Medical Research, LLC

Suwanee, Georgia, United States

Solaris Clinical Research

Meridian, Idaho, United States

DuPage Medical Group, Ltd

Lombard, Illinois, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

ActivMed Practices & Research

Methuen, Massachusetts, United States

StudyMetrix Research, LLC

City of Saint Peters, Missouri, United States

Mercury Street Medical

Butte, Montana, United States

Palm Research Center

Las Vegas, Nevada, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

PMG Research of Hickory, LLC

Hickory, North Carolina, United States

Lucas Research, Inc.

Morehead City, North Carolina, United States

PMG Research of Raleigh, LLC

Raleigh, North Carolina, United States

PMG Research of Piedmont Healthcare

Statesville, 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

Wake Forest University Health Sciences

Winston-Salem, 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

Dallas Diabetes and Endocrine Center

Dallas, Texas, United States

Clinical Trials of Texas, LLC

San Antonio, Texas, United States

Javara Research

Sugar Land, Texas, 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

Monash University

Box Hill, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Baker Heart and Diabetes Institute

Melbourne, Victoria, Australia

KH Rudolfstiftung, 1. Med. Abt., Wien

Vienna, , Austria

AKH - Medical University of Vienna

Vienna, , Austria

Cook Street Medical Clinic

Victoria, British Columbia, Canada

LMC Clinical Research Inc. (Brampton)

Brampton, Ontario, Canada

LMC Clinical Research Inc. (Thornhill)

Concord, Ontario, Canada

The Wharton Medical Clinic Clinical Trials Inc.

Hamilton, Ontario, Canada

Devonshire Clinical Research Inc.

Woodstock, Ontario, Canada

Manna Research (Quebec)

Lévis, Quebec, Canada

Centre Medical Acadie

Montreal, Quebec, Canada

Manna Research (Montreal)

Pointe-Claire, Quebec, Canada

Edumed s.r.o

Broumov, , Czechia

General Faculty Hospital, Prague

Prague, , Czechia

Studienzentrum Aschaffenburg

Aschaffenburg, , Germany

InnoDiab Forschung GmbH

Essen, , Germany

Institut für Diabetesforschung Münster GmbH

Münster, , Germany

DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured

Balatonfüred, , Hungary

Bajcsy-Zsilinszky Hospital and Clinic

Budapest, , Hungary

University Debrecen Hospital

Debrecen, , Hungary

Optimal Clinical Trials

Auckland, , New Zealand

P3 Research

Newtown Wellington NZ, , New Zealand

P3 Research Kapiti

Paraparaumu, , New Zealand

P3 Research

Tauranga, , New Zealand

In-Vivo Sp. Z o.o.

Bydgoszcz, , Poland

Vita Longa Sp. z o.o.

Katowice, , Poland

Pratia SA

Skorzewo, , Poland

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

Torun, , Poland

NBR Polska

Warsaw, , Poland

GCM Medical Group, PSC

San Juan, , Puerto Rico

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

Bucheon-si, , South Korea

Dongguk University Ilsan Hospital

Goyang, , South Korea

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Hospital A Coruña

A Coruña, , Spain

C.A.P. Sardenya

Barcelona, , Spain

Hospital Virgen de la Victoria

Málaga, , Spain

Hospital Clínico de Valencia

Valencia, , Spain

Chang-Hua Christian Hospital

Changhua, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

Waterloo Medical Centre

Blackpool, , United Kingdom

Burbage Surgery

Burbage, Hinkley, , United Kingdom

White Horse Medical Practice

Faringdon, , United Kingdom

Clifton Medical Centre, Rotherham

Rotherham, , United Kingdom

Moorgreen Hospital

Southampton, , United Kingdom

Countries

United States; Australia; Austria; Canada; Czechia; Germany; Hungary; New Zealand; Poland; Puerto Rico; South Korea; Spain; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38095657 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2019-002390-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1404-0002

Identifier Type: -

Identifier Source: org_study_id