Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

Plain-language guide to NCT02648204: phase 3 randomized trial of Semaglutide and Dulaglutide, 1201 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02648204
Phase: phase 3
Status: completed
Start: 2016-01-06
Completion (planned or actual): 2017-04-10
Participants: 1201 (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

This registered phase 3 trial tested Semaglutide and Dulaglutide.

This trial is conducted in Asia, Europe and the United States of America (USA).

It had four arms (groups): one (experimental), one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

1201 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

It was run as a randomized, parallel-group and open-label 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.

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

It started in 2016-01-06 with completion listed for 2017-04-10.

It ran at 209 sites in United States (100), India (26), Spain (9), Greece (8), United Kingdom (8) and Germany (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Week 0, week 40).

It also tracked 27 secondary outcomes, for example Change in Body Weight (kg), Change in Fasting Plasma Glucose, Change in Systolic and Diastolic Blood Pressure, Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire, Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile and Change From Baseline 7-point Self-measured Plasma Glucose Increment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Dulaglutide in 1201 people.

With 1201 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 Dulaglutide 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).

Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.

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.