Clinical trial NCT04153929: A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-11-06
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Further exclusion criteria apply.

Primary outcomes:
measure: Absolute Change in HbA1c From Baseline to 16 Weeks
timeFrame: At baseline and at Week 17 (16 weeks after treatment start).
Secondary outcomes:
measure: Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks
timeFrame: At baseline and at Week 17 (16 weeks after treatment start ).
measure: The Absolute Change in Body Weight From Baseline to 16 Weeks
timeFrame: At baseline and at Week 17 (16 weeks after treatment start).
measure: The Absolute Change in Waist Circumference From Baseline to 16 Weeks
timeFrame: At baseline and at Week 17 (16 weeks after treatment start).
measure: Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks
timeFrame: At baseline and at Week 17 (16 weeks after treatment start).
measure: Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks
timeFrame: At baseline and at Week 17 (16 weeks after treatment start).
Other outcomes:
Locations:
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Suwanee
country: United States
facility: In-Quest Medical Research, LLC
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Lombard
country: United States
facility: DuPage Medical Group, Ltd
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Saint Peters
country: United States
facility: StudyMetrix Research, LLC
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Statesville
country: United States
facility: PMG Research of Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Beaver
country: United States
facility: Heritage Valley Medical Group
state: Pennsylvania
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: Sugar Land
country: United States
facility: Javara Research
state: Texas
city: Camperdown
country: Australia
facility: Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders
state: New South Wales
city: Merewether
country: Australia
facility: Hunter Diabetes Centre
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Monash University
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
city: Vienna
country: Austria
facility: AKH - Medical University of Vienna
city: Wien
country: Austria
facility: KH Rudolfstiftung, 1. Med. Abt., Wien
city: Victoria
country: Canada
facility: Cook Street Medical Clinic
state: British Columbia
city: Brampton
country: Canada
facility: LMC Clinical Research Inc. (Brampton)
state: Ontario
city: Concord
country: Canada
facility: LMC Clinical Research Inc. (Thornhill)
state: Ontario
city: Hamilton
country: Canada
facility: The Wharton Medical Clinic Clinical Trials Inc.
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research Inc.
state: Ontario
city: Levis
country: Canada
facility: Manna Research (Quebec)
state: Quebec
city: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Pointe-Claire
country: Canada
facility: Manna Research (Montreal)
state: Quebec
city: Broumov
country: Czechia
facility: Edumed s.r.o
city: Prague 2
country: Czechia
facility: General Faculty Hospital, Prague
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Münster
country: Germany
facility: Institut für Diabetesforschung Münster GmbH
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital and Clinic
city: Debrecen
country: Hungary
facility: University Debrecen Hospital
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Newtown Wellington NZ
country: New Zealand
facility: P3 Research
city: Paraparaumu
country: New Zealand
facility: P3 Research Kapiti
city: Tauranga
country: New Zealand
facility: P3 Research
city: Bydgoszcz
country: Poland
facility: In-Vivo Sp. Z o.o.
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Skorzewo
country: Poland
facility: Pratia SA
city: Torun
country: Poland
facility: Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
city: Warsaw
country: Poland
facility: NBR Polska
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC
city: A Coruña
country: Spain
facility: Hospital A Coruña
city: Barcelona
country: Spain
facility: C.A.P. Sardenya
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Blackpool
country: United Kingdom
facility: Waterloo Medical Centre
city: Burbage, Hinkley
country: United Kingdom
facility: Burbage Surgery
city: Faringdon
country: United Kingdom
facility: White Horse Medical Practice
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre, Rotherham
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
Study officials:
References: