A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

Plain-language guide to NCT05514535: phase 3 randomized trial of Semaglutide and Insulin Glargine, 573 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05514535
Phase: phase 3
Status: completed
Start: 2022-08-29
Completion (planned or actual): 2025-03-05
Participants: 573 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes Mellitus, Type 2; Obesity
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide and Insulin Glargine.

The study looks at how well the study medicines control blood glucose levels.

It had two arms (groups): one (experimental) and Insuline glargine U100 (titrated) (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 573 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 6 inclusion and 6 exclusion criteria; among the exclusions: presence or history of pancreatitis (acute or chronic); any episodes of diabetic ketoacidosis within 90 days before screening; known hypoglycaemic unawareness as indicated by the investigator according to clarke's questionnaire question 8.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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 2022-08-29 with completion listed for 2025-03-05.

It ran at 239 sites in United States (145), Romania (16), Slovakia (13), Greece (12), Italy (11) and Portugal (11).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Change in Body Weight, Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc), Number of Severe Hypoglycaemic Episodes (Level 3), Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs) and Change in Score of Short Form 36 Version 2 (SF-36 v2).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Insulin Glargine in 573 people.

With 573 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 Insulin Glargine 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).

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

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.