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)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
573actual
Sites
239
Countries
Czechia, Greece, Italy +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-29 | actual | When the study began enrolling |
| Primary completion | 2025-03-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-09 | actual | The whole study's end, after follow-up |
| First posted | 2022-08-24 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-11 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diabetes Mellitus, Type 2
- Obesity
Interventions
- Drug: Semaglutide
- Drug: Insuline glargine U100 (reduced)
- Drug: Insuline glargine U100 (titrated)
Primary outcome
what the primary-completion date above is the date OFChange in Glycated Haemoglobin (HbA1c) [Noninferiority]
measured From baseline (week 0) to end of treatment (week 40)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-12 · 1.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-03-12 · 546 KB · SAP_001.pdf
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