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NCT04538352 · ClinicalTrials.gov registry record · Phase 4
Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT04538352: Completed Phase 4 study, sponsored by The Cleveland Clinic.
NCT04538352 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04538352, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study is designed to determine whether therapy with once-weekly sc semaglutide in combination with once-daily insulin degludec will be capable of maintaining (or improving) glycemic control, when substituted for multiple daily injections of insulin (MDI), in patients with T2D with adequate glycemic control (≤ 7.5%) on MDI-based regimens (≤ 80 units of insulin per day), vs. further titration of insulin therapy in those continuing MDI. Weight loss, hypoglycemic episodes, and improvement in diabetes-treatment satisfaction will also be assessed between the two groups.
Primary Outcome
Mean change in HbA1C ≤ 7.5% from baseline to 26 weeks between the two groups
Interventions
- DRUG Semaglutide
- DRUG Insulin aspart
- DRUG Insulin Degludec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2023-11-01 |
| Phase | Phase 4 |
What the finished NCT04538352 record still lists
NCT04538352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Semaglutide is the first listed.
NCT04538352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04538352 about?
NCT04538352 is a clinical study titled "Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D". This study is designed to determine whether therapy with once-weekly sc semaglutide in combination with once-daily insulin degludec will be capable of maintaining (or improving) glycemic control, when substituted for multiple daily injections of insulin (MDI), in patients with T2D with adequate glyc...
What is the current status of trial NCT04538352?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2021-01-18. Estimated completion is 2023-11-01.
What interventions are being tested in trial NCT04538352?
The interventions under investigation include: Semaglutide (DRUG), Insulin aspart (DRUG), Insulin Degludec (DRUG).
Who is sponsoring clinical trial NCT04538352?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04538352's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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