A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.

It had ten arms (groups): one (experimental), one (placebo comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 500 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: Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening. BMI greater than or equal to 25 and below 40 kg/m\^2.

The full record lists 4 inclusion and 3 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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 2021-11-29 with completion listed for 2023-02-13.

It ran at 129 sites in United States (71), Hungary (13), Poland (13), Greece (8), Bulgaria (7) and Japan (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Baseline (week 0), (week 34)).

It also tracked 14 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Body Weight (Kilogram [kg]), Percent Change From Baseline in Body Weight, Change From Baseline in Waist Circumference, Change From Baseline in Systolic Blood Pressure (SBP) and Relative Change From Baseline in Total Cholesterol - Ratio to Baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 500 people.

With 500 participants it is a large trial for this field.

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

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