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
Active, not recruiting
CT.gov ID
NCT04153929
Collaborator
(none)
413
Enrollment
80
Locations
7
Arms
18.2
Anticipated 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 DiseaseIntervention/TreatmentPhase
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
Anticipated Primary Completion Date :
Oct 8, 2021
Anticipated Study Completion Date :
Nov 5, 2021

Arms and Interventions

ArmIntervention/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

SiteCityStateCountryPostal Code
1National Research InstituteHuntington ParkCaliforniaUnited States90255
2National Research InstituteLos AngelesCaliforniaUnited States90057
3Valley Clinical Trials, Inc.NorthridgeCaliforniaUnited States91325
4Indago Research and Health CenterHialeahFloridaUnited States33012
5Meridien ResearchLakelandFloridaUnited States33803
6San Marcus Research Clinic, Inc.MiamiFloridaUnited States33014
7Renstar Medical ResearchOcalaFloridaUnited States34470
8Sensible Healthcare, LLCOcoeeFloridaUnited States34761
9Meridien ResearchSaint PetersburgFloridaUnited States33709
10In-Quest Medical Research, LLCSuwaneeGeorgiaUnited States30024
11Solaris Clinical ResearchMeridianIdahoUnited States83646
12DuPage Medical Group, LtdLombardIllinoisUnited States60148
13Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowaUnited States50265
14ActivMed Practices & ResearchMethuenMassachusettsUnited States01844
15StudyMetrix Research, LLCSaint PetersMissouriUnited States63303
16Mercury Street MedicalButteMontanaUnited States59701
17Palm Research CenterLas VegasNevadaUnited States89148
18The University of North Carolina at Chapel HillChapel HillNorth CarolinaUnited States27514
19PMG Research of Hickory, LLCHickoryNorth CarolinaUnited States28602
20Lucas Research, Inc.Morehead CityNorth CarolinaUnited States28557
21PMG Research of Raleigh, LLCRaleighNorth CarolinaUnited States27609
22PMG Research of Piedmont HealthcareStatesvilleNorth CarolinaUnited States28625
23PMG Research of Wilmington, LLCWilmingtonNorth CarolinaUnited States28401
24PMG Research of Winston-SalemWinston-SalemNorth CarolinaUnited States27103
25Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States27157
26Lillestol Research, LLCFargoNorth DakotaUnited States58104
27Heritage Valley Medical GroupBeaverPennsylvaniaUnited States15009
28PMG Research of KnoxvilleKnoxvilleTennesseeUnited States37938
29Dallas Diabetes and Endocrine CenterDallasTexasUnited States75230
30Clinical Trials of Texas, Inc.San AntonioTexasUnited States78229
31Javara ResearchSugar LandTexasUnited States77478
32Boden Institute of Obesity, Nutrition, Exercies and Eating DisordersCamperdownNew South WalesAustralia2006
33Hunter Diabetes CentreMerewetherNew South WalesAustralia2291
34Royal Adelaide HospitalAdelaideSouth AustraliaAustralia5000
35Monash UniversityBox HillVictoriaAustralia3128
36Austin HealthHeidelbergVictoriaAustralia3081
37Baker Heart and Diabetes InstituteMelbourneVictoriaAustralia3004
38AKH - Medical University of ViennaViennaAustria1090
39KH Rudolfstiftung, 1. Med. Abt., WienWienAustria1030
40Cook Street Medical ClinicVictoriaBritish ColumbiaCanadaV8V 4A1
41LMC Clinical Research Inc. (Brampton)BramptonOntarioCanadaL6S 0C6
42LMC Clinical Research Inc. (Thornhill)ConcordOntarioCanadaL4K 4M2
43The Wharton Medical Clinic Clinical Trials Inc.HamiltonOntarioCanadaL8L 5G8
44Devonshire Clinical Research Inc.WoodstockOntarioCanadaN4S 5P5
45Manna Research (Quebec)LevisQuebecCanadaG6W 0M5
46Centre Medical AcadieMontrealQuebecCanadaH4N 2W2
47Manna Research (Montreal)Pointe-ClaireQuebecCanadaH9R 4S3
48Edumed s.r.oBroumovCzechia55001
49General Faculty Hospital, PraguePrague 2Czechia128 08
50Studienzentrum AschaffenburgAschaffenburgGermany63739
51InnoDiab Forschung GmbHEssenGermany45136
52Institut für Diabetesforschung Münster GmbHMünsterGermany48145
53DRC Gyogyszervizsgalo Kozpont Kft., BalatonfuredBalatonfuredHungary8230
54Bajcsy-Zsilinszky Hospital and ClinicBudapestHungary1106
55University Debrecen HospitalDebrecenHungary4032
56The Catholic University of Korea, Bucheon St.Mary's HospitalBucheonKorea, Republic of14647
57Dongguk University Ilsan HospitalGoyangKorea, Republic of10326
58Kangdong Sacred Heart HospitalSeoulKorea, Republic of134701
59Optimal Clinical TrialsAucklandNew Zealand1010
60P3 ResearchNewtown Wellington NZNew Zealand6021
61P3 Research KapitiParaparaumuNew Zealand5032
62P3 ResearchTaurangaNew Zealand3110
63In-Vivo Sp. Z o.o.BydgoszczPoland85-048
64Vita Longa Sp. z o.o.KatowicePoland40-748
65Pratia SASkorzewoPoland60-185
66Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,TorunTorunPoland87-100
67NBR PolskaWarsawPoland00-465
68GCM Medical Group, PSCSan JuanPuerto Rico00917
69Hospital A CoruñaA CoruñaSpain15006
70C.A.P. SardenyaBarcelonaSpain08025
71Hospital Virgen de la VictoriaMalagaSpain29010
72Hospital Clínico de ValenciaValenciaSpain46010
73Chang-Hua Christian HospitalChanghuaTaiwan500
74Kaohsiung Chang Gung Memorial HospitalKaohsiungTaiwan83301
75Chung Shan Medical University HospitalTaichungTaiwan40201
76Waterloo Medical CentreBlackpoolUnited KingdomFY4 3AD
77Burbage SurgeryBurbage, HinkleyUnited KingdomLE10 2SE
78White Horse Medical PracticeFaringdonUnited KingdomSN7 7YU
79Clifton Medical Centre, RotherhamRotherhamUnited KingdomS65 1DA
80Moorgreen HospitalSouthamptonUnited KingdomSO30 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:
Oct 5, 2021
Last Verified:
Oct 1, 2021
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:

Study Results

No Results Posted as of Oct 5, 2021