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

• ClinicalTrials.gov Identifier: NCT04153929
• Recruitment Status: Completed
• First Posted: November 6, 2019
• Results First Posted: November 29, 2022
• Last Update Posted: November 29, 2022
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: November 5, 2019
• First Posted Date: November 6, 2019
• Results First Submitted Date: November 2, 2022
• Results First Posted Date: November 29, 2022
• Last Update Posted Date: November 29, 2022
• Actual Study Start Date: April 30, 2020
• Actual Primary Completion Date: October 8, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2022)

Absolute Change in HbA1c From Baseline to 16 Weeks [ Time Frame: At baseline and at Week 17 (16 weeks after treatment start). ]

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.

• Original Primary Outcome Measures (submitted: November 5, 2019): Absolute change in HbA1c from baseline to 16 weeks [ Time Frame: Baseline, 16 weeks ]

Current Secondary Outcome Measures (submitted: November 2, 2022)

• 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 ). ]
  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). ]
  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). ]
  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). ]
  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). ]
  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.

Original Secondary Outcome Measures (submitted: November 5, 2019)

• The relative body weight change from baseline to 16 weeks (key secondary endpoint) [ Time Frame: Baseline, 16 weeks ]
• The absolute body weight change from baseline to 16 weeks. [ Time Frame: Baseline, 16 weeks ]
• The absolute change in waist circumference from baseline to 16 weeks [ Time Frame: Baseline, 16 weeks ]
• The percentage of patients with 5% or greater body weight loss from baseline to 16 weeks [ Time Frame: Baseline, 16 weeks ]
• The percentage of patients with 10% or greater body weight loss from baseline to 16 weeks [ Time Frame: Baseline, 16 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose: Treatment

• Condition: Diabetes Mellitus, Type 2

Intervention

• Drug: BI 456906
  Solution for Injection
• Drug: Placebo
  Solution for Injection
• Drug: Semaglutide
  Solution for Injection

Study Arms

• Experimental: BI 456906 0.3 mg
  Intervention: Drug: BI 456906
• Experimental: BI 456906 0.9 mg
  Intervention: Drug: BI 456906
• Experimental: BI 456906 1.8 mg
  Intervention: Drug: BI 456906
• Experimental: BI 456906 2.7 mg
  Intervention: Drug: BI 456906
• Experimental: BI 456906 1.2 twice weekly (2.4) mg
  Intervention: Drug: BI 456906
• Experimental: BI 456906 1.8 twice weekly (3.6) mg
  Intervention: Drug: BI 456906
• Active Comparator: Semaglutide
  Intervention: Drug: Semaglutide
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2021): 413
• Original Estimated Enrollment (submitted: November 5, 2019): 410
• Actual Study Completion Date: November 4, 2021
• Actual Primary Completion Date: October 8, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Canada, Czechia, Germany, Hungary, Korea, Republic of, New Zealand, Poland, Puerto Rico, Spain, Taiwan, United Kingdom, United States
• Removed Location Countries: Italy

Administrative Information

• NCT Number: NCT04153929
• Other Study ID Numbers: 1404-0002; 2019-002390-60 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

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.

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• 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.
• 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'.
• URL: https://www.mystudywindow.com/msw/datasharing

• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boehringer Ingelheim
• Verification Date: November 2022