Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

Plain-language guide to NCT03061214: phase 3 randomized trial of Semaglutide, 868 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03061214
Phase: phase 3
Status: completed
Start: 2017-08-28
Completion (planned or actual): 2019-03-14
Participants: 868 (actual)
Design: randomized, double-blind, 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.

This trial is conducted in Africa, Asia, Europe and South America.

Subjects will remain on their stable pre-trial metformin.

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

868 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

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

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 2017-08-28 with completion listed for 2019-03-14.

It ran at 67 sites in China (39), South Korea (14), South Africa (4), Brazil (3), Taiwan (3) and Ukraine (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: Week 0, week 30).

It also tracked 73 secondary outcomes, for example Change in Body Weight, Change in Fasting Plasma Glucose (FPG), Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile, Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals, Change in Fasting Insulin - Ratio to Baseline and Change in Fasting C-peptide - Ratio to Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 868 people.

With 868 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.

Our Notes on the Compound

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

Semaglutide in the library

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.