Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted globally.

It had 13 arms (groups): one (experimental), one (active comparator), Placebo 50 µL (placebo comparator), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 706 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female, age at least 18 years at the time of signing informed consent. BMI: 25.0 - 40.0 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: simultaneous participation in any other clinical trial of an investigational medicinal product; history of pancreatitis (acute or chronic); screening calcitonin above or equal to 50 ng/l.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-09-21 with completion listed for 2016-10-13.

It ran at 150 sites in United States (84), United Kingdom (13), Czechia (9), Germany (9), Canada (8) and Russia (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26).

It also tracked 3 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Body Weight Change and Change in Systolic and Diastolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide and Liraglutide in 706 people.

With 706 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 and the Liraglutide compound page, all human trials.