1404-0002 Type 2 Diabetes Mellitus

• Research type

  Research Study

• Full 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.

• IRAS ID

  268955

• Contact name

  Matthew Capehorn

• Contact email

  matt@rioslim.co.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2019-002390-60

• Duration of Study in the UK

  1 years, 3 months, 26 days

• Research summary

  Research Summary

  The trial is to demonstrate a dose-relationship of BI 456906 on HbA1c (absolute change)from baseline to Week 16 relative to placebo in patients with Type 2 Diabetes. An open label comparator (semaglutide) will allow for comparison of the effects against a pure GLP-1 receptor agonist. Change in body weight will be evaluated as secondary endpoints. The primary objective is to demonstrate proof of clinical concept (PoCC) with respect to a non-flat dose response curve and to define a suitable dose escalation scheme and dose range for BI 456906 regarding safety, tolerability and efficacy for further pivotal testing in Phase 3. For this purpose, a multiple comparison procedure with modelling techniques (MCPMod)approach is considered.

  Summary of Results

  Study title:
  A study to test whether different doses of BI 456906 are effective in treating adults with type 2 diabetes This is a summary of results from 1 clinical study.
  We thank all study participants. You helped us to answer important questions about BI 456906 and the treatment of type 2 diabetes.

  What was this study about?
  The purpose of this study was to find the best dose of a medicine called BI 456906 that people with type 2 diabetes could take to reduce blood sugar.
  Type 2 diabetes occurs when the body cannot produce enough insulin or use it properly. As a result, people with type 2 diabetes have too much sugar in their blood. Over time, type 2 diabetes can cause medical problems like heart disease or kidney disease. Thus, people with type 2 diabetes need to control their blood sugar levels.

  Who took part in this study?
  People could take part in this study if they were between 18 and 75 years of age and had type 2 diabetes. People could take part if they still had too much blood sugar although they had been taking metformin for at least 3 months. Metformin is a common medicine for the treatment of type 2 diabetes.
  A total of 411 people took part in the study. There were 233 men and 178 women. The average age was 57 years. The youngest participant was 24 years old and the oldest participant was 75 years old.
  The following listing shows the numbers of participants in the study in different countries.
  Europe (153 participants): Austria (9), Czech Republic (17), Germany (10), Hungary (50), Poland (30), Spain (24), United Kingdom (13) North America (192 participants): Canada (40), United States (152) Asia (66 participants): Australia (24), South Korea (20), New Zealand (12), Taiwan (10) The total number of participants in the EU was 140.

  How was this study done?
  The participants were divided into 7 groups of almost equal size. Every participant had an equal chance of being in each group. Each group received a different dose of BI 456906. The groups were:
  • Groups 1, 2, 3, and 4: participants received 1 injection of BI 456906 per week.
  • Groups 5 and 6: participants received 2 injections of BI 456906 per week.
  • Group 7: participants received 1 injection of semaglutide per week. Semaglutide is a medicine that is used for the treatment of type 2 diabetes.
  1 out of 6 participants in groups 1 to 6 were assigned to receive placebo injections. Placebo injections looked like BI 456906 injections but did not contain any medicine. We compared BI 456906 with placebo to find out how well BI 456906 works. The participants and doctors did not know in which group (1 to 6) the participants were, only participants in group 7 had been told they were receiving semaglutide.
  Participants were in this study for 22 weeks. We wanted to find out whether the different doses of BI 456906 reduce blood sugar after 16 weeks of treatment.
  Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.

  What were the results of this study?
  All doses of BI 456906 reduced the levels of blood sugar after 16 weeks. The dose of BI 456906 that led to the largest reduction of blood sugar levels after 16 weeks was 1.8 mg once a week.

  Did participants have any unwanted effects?
  Yes, participants in all groups had unwanted effects. Unwanted effects are health problems that the doctors think were caused by BI 456906, the placebo, or semaglutide. In this study,
  • 177 participants (59%) who took BI 456906 had unwanted effects.
  • 13 participants (22%) in the placebo group had unwanted effects.
  • 19 participants (38%) in the semaglutide group had unwanted effects.
  The listing below shows the most common unwanted effects in the BI 456906, placebo, and semaglutide groups. The listing also shows how many participants had each of these unwanted effects.
  Nausea
  • BI 456906 (302 participants): 103 participants (34%)
  • Placebo (59 participants): 5 participants (8%)
  • Semaglutide (50 participants): 6 participants (12%)

  Vomiting
  • BI 456906 (302 participants): 54 participants (18%)
  • Placebo (59 participants): 1 participant (2%)
  • Semaglutide (50 participants): 2 participants (4%)

  Decreased appetite
  • BI 456906 (302 participants): 50 participants (17%)
  • Placebo (59 participants): 2 participants (3%)
  • Semaglutide (50 participants): 3 participants (6%)

  Diarrhoea
  • BI 456906 (302 participants): 48 participants (16%)
  • Placebo (59 participants): 5 participants (9%)
  • Semaglutide (50 participants): 4 participants (8%)

  Indigestion
  • BI 456906 (302 participants): 23 participants (8%)
  • Placebo (59 participants): 0 participants
  • Semaglutide (50 participants): 1 participant (2%)

  Headache
  • BI 456906 (302 participants): 15 participants (5%)
  • Placebo (59 participants): 1 participant (2%)
  • Semaglutide (50 participants): 0 participants

  Some unwanted effects were serious because they required a stay in hospital or a longer stay in hospital.
  In this study, 4 participants (1%) who took BI 456906 had serious unwanted effects.

  Where can I find more information about this study?
  You can find further information about this study at these websites:
  1. Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C01%7Capprovals%40hra.nhs.uk%7C92e241b8df6c4ae7d2a908dad48fd027%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638056011374751155%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=FcSJFkYwIy6kyRUo5FNfo2NPVKH8ITOl36oi69KImwg%3D&reserved=0 and search for the EudraCT number 2019-002390-60.
  2. Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C92e241b8df6c4ae7d2a908dad48fd027%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638056011374751155%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=bzPII3%2FATc14OYi2QJIMKgjYZF6kJ%2BosraRQse3h6vE%3D&reserved=0 and search for the NCT number NCT04153929.
  Boehringer Ingelheim sponsored this study. For contact details, please visit https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.boehringer-ingelheim.com%2Fcontact-us&data=05%7C01%7Capprovals%40hra.nhs.uk%7C92e241b8df6c4ae7d2a908dad48fd027%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638056011374751155%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fTiJ89Uiww0%2FOTe8kCPyi4uIgjIP9Kycny7QTnWWFuY%3D&reserved=0.
  The full title of the study is: 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.
  This study started in June 2020 and finished in November 2021.

  Are there additional studies?
  If we do more clinical studies with BI 456906, you will find them on the websites listed above. To search for these studies, use the word BI 456906.

  Important notice
  This lay summary is provided as part of Boehringer Ingelheim’s commitment to publicly share clinical study results.
  This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works and to determine the side effects of a medicine.
  This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may be approved or not approved in your country. This lay summary is not intended to promote any product or indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
  You should not change your therapy based on the results of this study. Always consult with your treating physician about your therapy.
  ©2022 Boehringer Ingelheim International GmbH

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  20/NW/0003

• Date of REC Opinion

  13 Feb 2020

• REC opinion

  Further Information Favourable Opinion