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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153929
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The main objective of the trial is to demonstrate a dose-relationship of BI 456906 on Glycosylated hemoglobin A1c (HbA1c)(absolute change) from baseline to 16 weeks relative to placebo in patients with Type 2 diabetes mellitus (T2DM).

Secondary objectives are to assess the effect of BI 456906 on change in body weight. An open-label comparator (semaglutide) will allow for comparison of the effects against a pure Glucagon-like-peptide 1 receptor (GLP-1R) agonist.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: BI 456906 Drug: Placebo Drug: Semaglutide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 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.
Estimated Study Start Date : March 31, 2020
Estimated Primary Completion Date : May 17, 2021
Estimated Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

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




Primary Outcome Measures :
  1. Absolute change in HbA1c from baseline to 16 weeks [ Time Frame: Baseline, 16 weeks ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  • 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 and men able to father a child 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 supine blood pressure ≥160/95 mmHg at screening.
  • A marked baseline prolongation of QT/QTc interval or any other clinically significant Electrocardiogram (ECG) finding at screening.
  • Body weight change of +/- 5% in the past 3 months or on anti-obesity therapies at any time during the 6 months prior to randomization.
  • Treatment for any clinical condition that requires continuous oral pharmacotherapy during the trial except for metformin, anti-hypertensives, thyroid hormone replacement, lipid lowering, proton pump inhibitors, H2 blockers for Gastric esophageal reflux disease (GERD), analgesics, and inhaled respiratory medications, with 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153929


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04153929    
Other Study ID Numbers: 1404-0002
2019-002390-60 ( EudraCT Number )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (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:// trials.boehringer‐ingelheim.com/trial_results/ clinical_submission_documents.html 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 http://trials.boehringeringelheim. com/ 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
Statistical Analysis Plan (SAP)
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://trials.boehringer‐ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases