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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04153929
Ethics application status
Date submitted
5/11/2019
Date registered
6/11/2019

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: BI 456906 0.3 mg -

Experimental: BI 456906 0.9 mg -

Experimental: BI 456906 1.8 mg -

Experimental: BI 456906 2.7 mg -

Experimental: BI 456906 1.2 twice weekly (2.4) mg -

Experimental: BI 456906 1.8 twice weekly (3.6) mg -

Active comparator: Semaglutide -

Placebo comparator: Placebo -


Treatment: Drugs: BI 456906
Solution for Injection

Treatment: Drugs: Placebo
Solution for Injection

Treatment: Drugs: Semaglutide
Solution for 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
At baseline and at Week 17 (16 weeks after treatment start).
Secondary outcome [1] 0 0
Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks
Timepoint [1] 0 0
At baseline and at Week 17 (16 weeks after treatment start ).
Secondary outcome [2] 0 0
The Absolute Change in Body Weight From Baseline to 16 Weeks
Timepoint [2] 0 0
At baseline and at Week 17 (16 weeks after treatment start).
Secondary outcome [3] 0 0
The Absolute Change in Waist Circumference From Baseline to 16 Weeks
Timepoint [3] 0 0
At baseline and at Week 17 (16 weeks after treatment start).
Secondary outcome [4] 0 0
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks
Timepoint [4] 0 0
At baseline and at Week 17 (16 weeks after treatment start).
Secondary outcome [5] 0 0
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks
Timepoint [5] 0 0
At baseline and at Week 17 (16 weeks after treatment start).

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
Sex
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 administering the treatment/s
The people assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/11/2021
Sample size
Target
Accrual to date
Final
413
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
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United States of America
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California
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United States of America
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Florida
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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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United States of America
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Iowa
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United States of America
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Massachusetts
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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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Vienna
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Austria
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Wien
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Canada
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British Columbia
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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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Germany
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Aschaffenburg
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Germany
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Essen
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Germany
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Münster
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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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Paraparaumu
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New Zealand
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Tauranga
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Poland
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Bydgoszcz
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Poland
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Katowice
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Poland
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Skorzewo
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Poland
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Torun
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Poland
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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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Spain
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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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United Kingdom
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Blackpool
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United Kingdom
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Burbage, Hinkley
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United Kingdom
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Faringdon
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United Kingdom
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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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04153929