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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04153929




Registration number
NCT04153929
Ethics application status
Date submitted
5/11/2019
Date registered
6/11/2019
Date last updated
1/12/2020

Titles & IDs
Public title
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
Scientific 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.
Secondary ID [1] 0 0
2019-002390-60
Secondary ID [2] 0 0
1404-0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 456906
Treatment: Drugs - Placebo
Treatment: Drugs - Semaglutide

Experimental: Dose group 1 -

Experimental: Dose group 2 -

Experimental: Dose group 3 -

Experimental: Dose group 4 -

Experimental: Dose group 5 -

Experimental: Dose group 6 -

Active Comparator: Dose group 7 (Semaglutide) -


Treatment: Drugs: BI 456906
Injection

Treatment: Drugs: Placebo
Injection

Treatment: Drugs: Semaglutide
Injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in HbA1c from baseline to 16 weeks
Timepoint [1] 0 0
Baseline, 16 weeks
Secondary outcome [1] 0 0
The relative body weight change from baseline to 16 weeks (key secondary endpoint)
Timepoint [1] 0 0
Baseline, 16 weeks
Secondary outcome [2] 0 0
The absolute body weight change from baseline to 16 weeks.
Timepoint [2] 0 0
Baseline, 16 weeks
Secondary outcome [3] 0 0
The absolute change in waist circumference from baseline to 16 weeks
Timepoint [3] 0 0
Baseline, 16 weeks
Secondary outcome [4] 0 0
The percentage of patients with 5% or greater body weight loss from baseline to 16 weeks
Timepoint [4] 0 0
Baseline, 16 weeks
Secondary outcome [5] 0 0
The percentage of patients with 10% or greater body weight loss from baseline to 16 weeks
Timepoint [5] 0 0
Baseline, 16 weeks

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders - Camperdown
Recruitment hospital [2] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Monash University - Box Hill
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
2006 - Camperdown
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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Iowa
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United States of America
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Kansas
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United States of America
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Massachusetts
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United States of America
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Missouri
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Montana
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Nevada
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North Carolina
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North Dakota
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Pennsylvania
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Tennessee
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United States of America
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Texas
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Austria
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Graz
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Austria
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Vienna
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Austria
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Wien
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Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
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Ontario
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Canada
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Quebec
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Czechia
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Broumov
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Czechia
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Prague 2
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Hungary
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Balatonfured
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Hungary
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Budapest
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Hungary
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Debrecen
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Korea, Republic of
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Bucheon
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Korea, Republic of
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Goyang
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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New Zealand
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Newtown Wellington NZ
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New Zealand
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Tauranga
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New Zealand
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Waikanae
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Poland
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Bydgoszcz
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Poland
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Katowice
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Skorzewo
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Szczecin
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Torun
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Warsaw
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Puerto Rico
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San Juan
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Spain
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A Coruña
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Barcelona
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Spain
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Malaga
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan,
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United Kingdom
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Blackpool
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United Kingdom
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Burbage, Hinkley
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Faringdon
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Rotherham
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main objective of the trial is to demonstrate a dose-relationship of BI 456906 on
Glycosylated hemoglobin A1c (HbA1c)(absolute change) from baseline to 16 weeks relative to
placebo in patients with Type 2 diabetes mellitus (T2DM).

Secondary objectives are to assess the effect of BI 456906 on change in body weight. An
open-label comparator (semaglutide) will allow for comparison of the effects against a pure
Glucagon-like-peptide 1 receptor (GLP-1R) agonist.
Trial website
https://clinicaltrials.gov/show/NCT04153929
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04153929