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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 456906
Placebo
Semaglutide
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Research Institute
  • National Research Institute
  • Valley Clinical Trials, Inc.
  • Indago Research and Health Center
  • Meridien Research
  • San Marcus Research Clinic, Inc.
  • Renstar Medical Research
  • Sensible Healthcare, LLC
  • Meridien Research
  • In-Quest Medical Research, LLC
  • Solaris Clinical Research
  • DuPage Medical Group, Ltd
  • Iowa Diabetes and Endocrinology Research Center
  • ActivMed Practices & Research
  • StudyMetrix Research, LLC
  • Mercury Street Medical
  • Palm Research Center
  • The University of North Carolina at Chapel Hill
  • PMG Research of Hickory, LLC
  • Lucas Research, Inc.
  • PMG Research of Raleigh, LLC
  • PMG Research of Piedmont Healthcare
  • PMG Research of Wilmington, LLC
  • PMG Research of Winston-Salem
  • Wake Forest University Health Sciences
  • Lillestol Research, LLC
  • Heritage Valley Medical Group
  • PMG Research of Knoxville
  • Dallas Diabetes and Endocrine Center
  • Clinical Trials of Texas, LLC
  • Javara Research
  • Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders
  • Hunter Diabetes Centre
  • Royal Adelaide Hospital
  • Monash University
  • Austin Health
  • Baker Heart and Diabetes Institute
  • AKH - Medical University of Vienna
  • KH Rudolfstiftung, 1. Med. Abt., Wien
  • Cook Street Medical Clinic
  • LMC Clinical Research Inc. (Brampton)
  • LMC Clinical Research Inc. (Thornhill)
  • The Wharton Medical Clinic Clinical Trials Inc.
  • Devonshire Clinical Research Inc.
  • Manna Research (Quebec)
  • Centre Medical Acadie
  • Manna Research (Montreal)
  • Edumed s.r.o
  • General Faculty Hospital, Prague
  • Studienzentrum Aschaffenburg
  • InnoDiab Forschung GmbH
  • Institut für Diabetesforschung Münster GmbH
  • DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured
  • Bajcsy-Zsilinszky Hospital and Clinic
  • University Debrecen Hospital
  • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Dongguk University Ilsan Hospital
  • Kangdong Sacred Heart Hospital
  • Optimal Clinical Trials
  • P3 Research
  • P3 Research Kapiti
  • P3 Research
  • In-Vivo Sp. Z o.o.
  • Vita Longa Sp. z o.o.
  • Pratia SA
  • Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
  • NBR Polska
  • GCM Medical Group, PSC
  • Hospital A Coruña
  • C.A.P. Sardenya
  • Hospital Virgen de la Victoria
  • Hospital Clínico de Valencia
  • Chang-Hua Christian Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Chung Shan Medical University Hospital
  • Waterloo Medical Centre
  • Burbage Surgery
  • White Horse Medical Practice
  • Clifton Medical Centre, Rotherham
  • Moorgreen Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

BI 456906 0.3 mg

BI 456906 0.9 mg

BI 456906 1.8 mg

BI 456906 2.7 mg

BI 456906 1.2 twice weekly (2.4) mg

BI 456906 1.8 twice weekly (3.6) mg

Semaglutide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 5, 2019
Last Updated
November 2, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04153929
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The trial has a double blind design within each dose group. Patients, investigators and everyone involved in trial conduct or analysis or with any other interest in this trial will remain blinded with regard to the randomized treatment assignments until after database lock. The semaglutide group is open label.
Allocation
Randomized
Enrollment
413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 456906 0.3 mg
Arm Type
Experimental
Arm Title
BI 456906 0.9 mg
Arm Type
Experimental
Arm Title
BI 456906 1.8 mg
Arm Type
Experimental
Arm Title
BI 456906 2.7 mg
Arm Type
Experimental
Arm Title
BI 456906 1.2 twice weekly (2.4) mg
Arm Type
Experimental
Arm Title
BI 456906 1.8 twice weekly (3.6) mg
Arm Type
Experimental
Arm Title
Semaglutide
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BI 456906
Intervention Description
Solution for Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for Injection
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Solution for Injection
Primary Outcome Measure Information:
Title
Absolute Change in HbA1c From Baseline to 16 Weeks
Description
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.
Time Frame
At baseline and at Week 17 (16 weeks after treatment start).
Secondary Outcome Measure Information:
Title
Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks
Description
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.
Time Frame
At baseline and at Week 17 (16 weeks after treatment start ).
Title
The Absolute Change in Body Weight From Baseline to 16 Weeks
Description
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.
Time Frame
At baseline and at Week 17 (16 weeks after treatment start).
Title
The Absolute Change in Waist Circumference From Baseline to 16 Weeks
Description
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.
Time Frame
At baseline and at Week 17 (16 weeks after treatment start).
Title
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks
Description
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.
Time Frame
At baseline and at Week 17 (16 weeks after treatment start).
Title
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks
Description
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.
Time Frame
At baseline and at Week 17 (16 weeks after treatment start).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
In-Quest Medical Research, LLC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
DuPage Medical Group, Ltd
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
ActivMed Practices & Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
StudyMetrix Research, LLC
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Lucas Research, Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
PMG Research of Piedmont Healthcare
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Lillestol Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Heritage Valley Medical Group
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Javara Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia
Facility Name
Hunter Diabetes Centre
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
2291
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash University
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Baker Heart and Diabetes Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
AKH - Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
KH Rudolfstiftung, 1. Med. Abt., Wien
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Cook Street Medical Clinic
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
LMC Clinical Research Inc. (Brampton)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
LMC Clinical Research Inc. (Thornhill)
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
The Wharton Medical Clinic Clinical Trials Inc.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Devonshire Clinical Research Inc.
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
Manna Research (Quebec)
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Centre Medical Acadie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
Manna Research (Montreal)
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Edumed s.r.o
City
Broumov
ZIP/Postal Code
55001
Country
Czechia
Facility Name
General Faculty Hospital, Prague
City
Prague 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Studienzentrum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
InnoDiab Forschung GmbH
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Institut für Diabetesforschung Münster GmbH
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Bajcsy-Zsilinszky Hospital and Clinic
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
University Debrecen Hospital
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
The Catholic University of Korea, Bucheon St.Mary's Hospital
City
Bucheon
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Dongguk University Ilsan Hospital
City
Goyang
ZIP/Postal Code
10326
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134701
Country
Korea, Republic of
Facility Name
Optimal Clinical Trials
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
P3 Research
City
Newtown Wellington NZ
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
P3 Research Kapiti
City
Paraparaumu
ZIP/Postal Code
5032
Country
New Zealand
Facility Name
P3 Research
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
In-Vivo Sp. Z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Vita Longa Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Pratia SA
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
NBR Polska
City
Warsaw
ZIP/Postal Code
00-465
Country
Poland
Facility Name
GCM Medical Group, PSC
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Hospital A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
C.A.P. Sardenya
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Chang-Hua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Waterloo Medical Centre
City
Blackpool
ZIP/Postal Code
FY4 3AD
Country
United Kingdom
Facility Name
Burbage Surgery
City
Burbage, Hinkley
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
White Horse Medical Practice
City
Faringdon
ZIP/Postal Code
SN7 7YU
Country
United Kingdom
Facility Name
Clifton Medical Centre, Rotherham
City
Rotherham
ZIP/Postal Code
S65 1DA
Country
United Kingdom
Facility Name
Moorgreen Hospital
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

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

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