Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Plain-language guide to NCT03191396: phase 3 randomized trial of Semaglutide and Liraglutide, 577 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03191396
Phase: phase 3
Status: completed
Start: 2017-06-27
Completion (planned or actual): 2018-07-09
Participants: 577 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes; Diabetes Mellitus, Type 2
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Semaglutide and Liraglutide.

This study is conducted in Europe.

The study will last approximately 9 months (37 weeks).

It had two arms (groups): Semaglutide (experimental) and Liraglutide (active comparator).

Half the study participants are randomised to receive semaglutide.

Half the study participants are randomised to receive liraglutide.

The registry classes the interventions as drug.

Who Took Part

577 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.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2017-06-27 with completion listed for 2018-07-09.

It ran at 92 sites in United Kingdom (17), France (15), Bulgaria (9), Finland (8), Hungary (8) and Germany (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Week 0, week 30).

It also tracked 40 secondary outcomes, for example Change in Body Weight (kg), Change in Fasting Plasma Glucose (FPG), Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile, Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals), Change in Fasting Blood Lipids: Total Cholesterol and Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Liraglutide in 577 people.

With 577 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.

Our Notes on the Compounds

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.