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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153929
• Other study ID #: 1404-0002
• Secondary ID: 2019-002390-60
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2020
• Est. completion date: November 4, 2021

Study information

• Verified date: November 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: November 4, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• BI 456906
Solution for Injection
• Placebo
Solution for Injection
• Semaglutide
Solution for Injection

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Monash University	Box Hill	Victoria
Australia	Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders	Camperdown	New South Wales
Australia	Austin Health	Heidelberg	Victoria
Australia	Baker Heart and Diabetes Institute	Melbourne	Victoria
Australia	Hunter Diabetes Centre	Merewether	New South Wales
Austria	AKH - Medical University of Vienna	Vienna
Austria	KH Rudolfstiftung, 1. Med. Abt., Wien	Wien
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	Manna Research (Quebec)	Levis	Quebec
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	Manna Research (Montreal)	Pointe-Claire	Quebec
Canada	Cook Street Medical Clinic	Victoria	British Columbia
Canada	Devonshire Clinical Research Inc.	Woodstock	Ontario
Czechia	Edumed s.r.o	Broumov
Czechia	General Faculty Hospital, Prague	Prague 2
Germany	Studienzentrum Aschaffenburg	Aschaffenburg
Germany	InnoDiab Forschung GmbH	Essen
Germany	Institut für Diabetesforschung Münster GmbH	Münster
Hungary	DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured	Balatonfured
Hungary	Bajcsy-Zsilinszky Hospital and Clinic	Budapest
Hungary	University Debrecen Hospital	Debrecen
Korea, Republic of	The Catholic University of Korea, Bucheon St.Mary's Hospital	Bucheon
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	P3 Research	Newtown Wellington NZ
New Zealand	P3 Research Kapiti	Paraparaumu
New Zealand	P3 Research	Tauranga
Poland	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
Puerto Rico	GCM Medical Group, PSC	San Juan
Spain	Hospital A Coruña	A Coruña
Spain	C.A.P. Sardenya	Barcelona
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital Clínico de Valencia	Valencia
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung
United Kingdom	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 States	Heritage Valley Medical Group	Beaver	Pennsylvania
United States	Mercury Street Medical	Butte	Montana
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Indago Research and Health Center	Hialeah	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	National Research Institute	Huntington Park	California
United States	PMG Research of Knoxville	Knoxville	Tennessee
United States	Meridien Research	Lakeland	Florida
United States	Palm Research Center	Las Vegas	Nevada
United States	DuPage Medical Group, Ltd	Lombard	Illinois
United States	National Research Institute	Los Angeles	California
United States	Solaris Clinical Research	Meridian	Idaho
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	Lucas Research, Inc.	Morehead City	North Carolina
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Renstar Medical Research	Ocala	Florida
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	StudyMetrix Research, LLC	Saint Peters	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	PMG Research of Piedmont Healthcare	Statesville	North Carolina
United States	Javara Research	Sugar Land	Texas
United States	In-Quest Medical Research, LLC	Suwanee	Georgia
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czechia,  Germany,  Hungary,  Korea, Republic of,  New Zealand,  Poland,  Puerto Rico,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 ).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).

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