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

What Was Tested

The trial (phase 2) is built around Semaglutide and Survodutide.

This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar.

The study also looks at whether BI 456906 helps the participants lose weight.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and BI 456906 1.2 twice weekly (2.4) mg (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 413 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Body mass index (BMI) 25 kg/m2-50 kg/m2 (both inclusive) at screening.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: patients with type 1 diabetes; 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-04-30 with completion listed for 2021-10-08.

It ran at 80 sites in United States (31), Canada (8), Australia (6), Poland (5), United Kingdom (5) and New Zealand (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absolute Change in HbA1c From Baseline to 16 Weeks (time frame: At baseline and at Week 17 (16 weeks after treatment start)).

It also tracked 5 secondary outcomes, for example Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks, The Absolute Change in Body Weight From Baseline to 16 Weeks and The Absolute Change in Waist Circumference From Baseline to 16 Weeks.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide and Survodutide in 413 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page and the Survodutide compound page, all human trials.