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SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

Plain-language guide to NCT04287179: phase 3 randomized trial of Semaglutide. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04287179
Phase
phase 3
Status
withdrawn
Start
2020-03-09
Completion (planned or actual)
2020-11-16
Participants
n/a (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Diabetes Mellitus, Type 2
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Semaglutide.

People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide.

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

The registry classes the interventions as drug.

Who 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 18 years or older at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator.

The full record lists 5 inclusion and 3 exclusion criteria.

How the Study Was Run

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

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.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2020-03-09 with completion listed for 2020-11-16.

It ran at 25 sites in United States (14), Finland (5), Austria (4) and Sweden (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in glycosylated haemoglobin (HbA1c) (time frame: From baseline (week 0) to week 12).

It also tracked 7 secondary outcomes, for example Change in fasting plasma glucose, Change in body weight, Number of treatment emergent adverse events (TEAEs), Number of treatment emergent gastrointestinal adverse events, Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes and Change in pulse rate.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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).

Related Pages

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.