A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

What Was Tested

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

This trial was conducted in Europe,Asia and Africa.

It had 14 arms (groups): A (experimental), B (experimental), C (experimental), D (experimental) and E (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 415 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: Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months. Body weight between 60 kg and 110 kg.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: treatment with insulin, glp-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, alpha-gis, or any investigational drug, within the last three months; impaired liver or kidney function; proliferative retinopathy or maculopathy requiring acute treatment.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2008-06-03 with completion listed for 2009-02-05.

It ran at 77 sites in United Kingdom (11), Austria (8), Germany (7), Bulgaria (6), Finland (6) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: After 12 weeks of treatment).

It also tracked 34 secondary outcomes, for example Percentage of Subjects With an Adverse Events, Percentage of Subjects With Hypoglycaemic Episode, Change From Baseline in ECG, Change From Baseline in Vital Signs (Pulse), Change From Baseline in Vital Signs (Blood Pressure; SBP) and Change From Baseline in Vital Signs (Blood Pressure; DBP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide and Liraglutide in 415 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 Liraglutide compound page, all human trials.