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NCT05514535 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 573
- Enrollment target
NCT05514535: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT05514535 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 573 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05514535, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 573 participants
- Enrollment target
Study Summary
This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.
Primary Outcome
Change in HbA1c (Noninferiority) from baseline (Week 0) to end of treatment (Week 40) were reported. Here noninferiority was assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.
Interventions
- DRUG Semaglutide
- DRUG Insuline glargine U100 (reduced)
- DRUG Insuline glargine U100 (titrated)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 573 participants |
| Start Date | 2022-08-29 |
| Est. Completion | 2025-04-09 |
| Phase | Phase 3 |
What the finished NCT05514535 record still lists
NCT05514535 is an interventional study that assigns participants to a tested intervention. The registered 573 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Semaglutide is the first listed.
NCT05514535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05514535 about?
NCT05514535 is a clinical study titled "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)". This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dos...
What is the current status of trial NCT05514535?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 573 participants. The study started on 2022-08-29. Estimated completion is 2025-04-09.
What interventions are being tested in trial NCT05514535?
The interventions under investigation include: Semaglutide (DRUG), Insuline glargine U100 (reduced) (DRUG), Insuline glargine U100 (titrated) (DRUG).
Who is sponsoring clinical trial NCT05514535?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05514535's enrollment target sits among peer trials
573 663rd of 2000 higher than 1,338 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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