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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04153929
Collaborator
(none)
413
Enrollment
80
Locations
7
Arms
18.2
Actual Duration (Months)
5.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
413 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Apr 30, 2020
Actual Primary Completion Date :
Oct 8, 2021
Actual Study Completion Date :
Nov 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose group 1

Drug: BI 456906
Injection

Drug: Placebo
Injection
Experimental: Dose group 2

Drug: BI 456906
Injection

Drug: Placebo
Injection
Experimental: Dose group 3

Drug: BI 456906
Injection

Drug: Placebo
Injection
Experimental: Dose group 4

Drug: BI 456906
Injection

Drug: Placebo
Injection
Experimental: Dose group 5

Drug: BI 456906
Injection

Drug: Placebo
Injection
Experimental: Dose group 6

Drug: BI 456906
Injection

Drug: Placebo
Injection
Active Comparator: Dose group 7 (Semaglutide)

Drug: Semaglutide
Injection

Outcome Measures

Primary Outcome Measures

  1. Absolute change in HbA1c from baseline to 16 weeks [Baseline, 16 weeks]

Secondary Outcome Measures

  1. The relative body weight change from baseline to 16 weeks (key secondary endpoint) [Baseline, 16 weeks]

  2. The absolute body weight change from baseline to 16 weeks. [Baseline, 16 weeks]

  3. The absolute change in waist circumference from baseline to 16 weeks [Baseline, 16 weeks]

  4. The percentage of patients with 5% or greater body weight loss from baseline to 16 weeks [Baseline, 16 weeks]

  5. The percentage of patients with 10% or greater body weight loss from baseline to 16 weeks [Baseline, 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Research Institute Huntington Park California United States 90255
2 National Research Institute Los Angeles California United States 90057
3 Valley Clinical Trials, Inc. Northridge California United States 91325
4 Indago Research and Health Center Hialeah Florida United States 33012
5 Meridien Research Lakeland Florida United States 33803
6 San Marcus Research Clinic, Inc. Miami Florida United States 33014
7 Renstar Medical Research Ocala Florida United States 34470
8 Sensible Healthcare, LLC Ocoee Florida United States 34761
9 Meridien Research Saint Petersburg Florida United States 33709
10 In-Quest Medical Research, LLC Suwanee Georgia United States 30024
11 Solaris Clinical Research Meridian Idaho United States 83646
12 DuPage Medical Group, Ltd Lombard Illinois United States 60148
13 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
14 ActivMed Practices & Research Methuen Massachusetts United States 01844
15 StudyMetrix Research, LLC Saint Peters Missouri United States 63303
16 Mercury Street Medical Butte Montana United States 59701
17 Palm Research Center Las Vegas Nevada United States 89148
18 The University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27514
19 PMG Research of Hickory, LLC Hickory North Carolina United States 28602
20 Lucas Research, Inc. Morehead City North Carolina United States 28557
21 PMG Research of Raleigh, LLC Raleigh North Carolina United States 27609
22 PMG Research of Piedmont Healthcare Statesville North Carolina United States 28625
23 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
24 PMG Research of Winston-Salem Winston-Salem North Carolina United States 27103
25 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
26 Lillestol Research, LLC Fargo North Dakota United States 58104
27 Heritage Valley Medical Group Beaver Pennsylvania United States 15009
28 PMG Research of Knoxville Knoxville Tennessee United States 37938
29 Dallas Diabetes and Endocrine Center Dallas Texas United States 75230
30 Clinical Trials of Texas, LLC San Antonio Texas United States 78229
31 Javara Research Sugar Land Texas United States 77478
32 Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders Camperdown New South Wales Australia 2006
33 Hunter Diabetes Centre Merewether New South Wales Australia 2291
34 Royal Adelaide Hospital Adelaide South Australia Australia 5000
35 Monash University Box Hill Victoria Australia 3128
36 Austin Health Heidelberg Victoria Australia 3081
37 Baker Heart and Diabetes Institute Melbourne Victoria Australia 3004
38 AKH - Medical University of Vienna Vienna Austria 1090
39 KH Rudolfstiftung, 1. Med. Abt., Wien Wien Austria 1030
40 Cook Street Medical Clinic Victoria British Columbia Canada V8V 4A1
41 LMC Clinical Research Inc. (Brampton) Brampton Ontario Canada L6S 0C6
42 LMC Clinical Research Inc. (Thornhill) Concord Ontario Canada L4K 4M2
43 The Wharton Medical Clinic Clinical Trials Inc. Hamilton Ontario Canada L8L 5G8
44 Devonshire Clinical Research Inc. Woodstock Ontario Canada N4S 5P5
45 Manna Research (Quebec) Levis Quebec Canada G6W 0M5
46 Centre Medical Acadie Montreal Quebec Canada H4N 2W2
47 Manna Research (Montreal) Pointe-Claire Quebec Canada H9R 4S3
48 Edumed s.r.o Broumov Czechia 55001
49 General Faculty Hospital, Prague Prague 2 Czechia 128 08
50 Studienzentrum Aschaffenburg Aschaffenburg Germany 63739
51 InnoDiab Forschung GmbH Essen Germany 45136
52 Institut für Diabetesforschung Münster GmbH Münster Germany 48145
53 DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured Balatonfured Hungary 8230
54 Bajcsy-Zsilinszky Hospital and Clinic Budapest Hungary 1106
55 University Debrecen Hospital Debrecen Hungary 4032
56 The Catholic University of Korea, Bucheon St.Mary's Hospital Bucheon Korea, Republic of 14647
57 Dongguk University Ilsan Hospital Goyang Korea, Republic of 10326
58 Kangdong Sacred Heart Hospital Seoul Korea, Republic of 134701
59 Optimal Clinical Trials Auckland New Zealand 1010
60 P3 Research Newtown Wellington NZ New Zealand 6021
61 P3 Research Kapiti Paraparaumu New Zealand 5032
62 P3 Research Tauranga New Zealand 3110
63 In-Vivo Sp. Z o.o. Bydgoszcz Poland 85-048
64 Vita Longa Sp. z o.o. Katowice Poland 40-748
65 Pratia SA Skorzewo Poland 60-185
66 Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun Torun Poland 87-100
67 NBR Polska Warsaw Poland 00-465
68 GCM Medical Group, PSC San Juan Puerto Rico 00917
69 Hospital A Coruña A Coruña Spain 15006
70 C.A.P. Sardenya Barcelona Spain 08025
71 Hospital Virgen de la Victoria Malaga Spain 29010
72 Hospital Clínico de Valencia Valencia Spain 46010
73 Chang-Hua Christian Hospital Changhua Taiwan 500
74 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 83301
75 Chung Shan Medical University Hospital Taichung Taiwan 40201
76 Waterloo Medical Centre Blackpool United Kingdom FY4 3AD
77 Burbage Surgery Burbage, Hinkley United Kingdom LE10 2SE
78 White Horse Medical Practice Faringdon United Kingdom SN7 7YU
79 Clifton Medical Centre, Rotherham Rotherham United Kingdom S65 1DA
80 Moorgreen Hospital Southampton United Kingdom SO30 3JB

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04153929
Other Study ID Numbers:
  • 1404-0002
  • 2019-002390-60
First Posted:
Nov 6, 2019
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 23, 2022