Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT04153929Other id1404-0002Other id2019-002390-60Other id2019

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 413 participants (actual)
Sponsor: Boehringer Ingelheim · Industry
Design: Randomized · Quadruple masking
Countries: 14 countries
United States, Australia, Austria, Canada, Czechia, Germany, Hungary, New Zealand, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom
Start: 30 Apr 2020
Primary completion: 8 Oct 2021
Completion: 4 Nov 2021
First posted: 6 Nov 2019
Last update posted: 29 Nov 2022
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph 2
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
NCT04153929
30 Apr 2020 to 4 Nov 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

BI 456906Drug
PlaceboDrug
SemaglutideDrug

Arms8

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Absolute Change in HbA1c From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
Registry 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.

Secondary outcomes(5)

Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start ).
Registry 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.
The Absolute Change in Body Weight From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
Registry 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.
The Absolute Change in Waist Circumference From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
Registry 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.
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
Registry 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.
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· At baseline and at Week 17 (16 weeks after treatment start).

Absolute Change in HbA1c From Baseline to 16 Weeks

Group	Value (percentage (%) of HbA1c)	Spread
Placebo	-0.23	0.81
BI 456906 0.3 mg	-0.91	0.71
BI 456906 0.9 mg	-1.37	0.93
BI 456906 1.8 mg	-1.79	0.92
BI 456906 2.7 mg	-1.67	0.78
BI 456906 1.2 Twice Weekly (2.4) mg	-1.68	0.90
BI 456906 1.8 Twice Weekly (3.6) mg	-1.79	0.76
Semaglutide	-1.50	0.84

Secondary and other outcome results(5)

Secondary outcomeMean· At baseline and at Week 17 (16 weeks after treatment start ).

Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks

Group	Value (percentage of body weight change)	Spread
Placebo	-1.20	3.52
BI 456906 0.3 mg	-1.86	2.91
BI 456906 0.9 mg	-4.43	3.92
BI 456906 1.8 mg	-6.63	5.13
BI 456906 2.7 mg	-6.68	4.05
BI 456906 1.2 Twice Weekly (2.4) mg	-7.16	6.06
BI 456906 1.8 Twice Weekly (3.6) mg	-8.95	5.33
Semaglutide	-5.40	4.33

Secondary outcomeMean· At baseline and at Week 17 (16 weeks after treatment start).

The Absolute Change in Body Weight From Baseline to 16 Weeks

Group	Value (kilogram (kg))	Spread
Placebo	-1.28	3.05
BI 456906 0.3 mg	-1.90	3.12
BI 456906 0.9 mg	-4.41	4.07
BI 456906 1.8 mg	-6.31	4.53
BI 456906 2.7 mg	-6.88	4.41
BI 456906 1.2 Twice Weekly (2.4) mg	-6.75	6.10
BI 456906 1.8 Twice Weekly (3.6) mg	-8.88	4.93
Semaglutide	-5.18	4.52

Secondary outcomeMean· At baseline and at Week 17 (16 weeks after treatment start).

The Absolute Change in Waist Circumference From Baseline to 16 Weeks

Group	Value (centimeter)	Spread
Placebo	-1.95	9.08
BI 456906 0.3 mg	-2.73	10.49
BI 456906 0.9 mg	-1.80	10.55
BI 456906 1.8 mg	-3.63	10.94
BI 456906 2.7 mg	-7.47	12.24
BI 456906 1.2 Twice Weekly (2.4) mg	-4.61	9.73
BI 456906 1.8 Twice Weekly (3.6) mg	-12.89	25.50
Semaglutide	-3.63	5.05

Secondary outcomeNumber· At baseline and at Week 17 (16 weeks after treatment start).

Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks

Group	Value (percentage of patients)
Placebo	6.8
BI 456906 0.3 mg	8.0
BI 456906 0.9 mg	38.0
BI 456906 1.8 mg	42.3
BI 456906 2.7 mg	46.0
BI 456906 1.2 Twice Weekly (2.4) mg	56.9
BI 456906 1.8 Twice Weekly (3.6) mg	57.1
Semaglutide	38.0

Secondary outcomeNumber· At baseline and at Week 17 (16 weeks after treatment start).

Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks

Group	Value (percentage of patients)
Placebo	0.0
BI 456906 0.3 mg	2.0
BI 456906 0.9 mg	6.0
BI 456906 1.8 mg	13.5
BI 456906 2.7 mg	16.0
BI 456906 1.2 Twice Weekly (2.4) mg	25.5
BI 456906 1.8 Twice Weekly (3.6) mg	34.7
Semaglutide	16.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboThis arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	0 / 59	3 / 59	18 / 59
BI 456906 0.3 mgPatients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	0 / 50	1 / 50	27 / 50
BI 456906 0.9 mgPatients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	0 / 50	4 / 50	30 / 50
BI 456906 1.8 mgPatients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	0 / 52	3 / 52	40 / 52
BI 456906 2.7 mgPatients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	0 / 50	2 / 50	33 / 50
BI 456906 1.2 Twice Weekly (2.4) mgPatients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	0 / 51	1 / 51	33 / 51
BI 456906 1.8 Twice Weekly (3.6) mgPatients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	0 / 49	0 / 49	37 / 49
SemaglutidePatients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.	0 / 50	0 / 50	20 / 50

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

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Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity.

Ekinci et al. 2026Diabetes, obesity & metabolismcited by 1

PMID 42331726PMC13448873DOI 10.1111/dom.70861PUB-42331726

Free to read · publisher termsCC BY-NC15 results

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Indexing hint: Randomized controlled trial · 2024

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CC BY

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Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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