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NCT03021187 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 731
- Enrollment target
NCT03021187: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT03021187 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 731 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03021187, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 731 participants
- Enrollment target
Study Summary
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.
Primary Outcome
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medic
Interventions
- DRUG placebo
- DRUG semaglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 731 participants |
| Start Date | 2017-02-02 |
| Est. Completion | 2018-08-22 |
| Phase | Phase 3 |
What the finished NCT03021187 record still lists
NCT03021187 is an interventional study that assigns participants to a tested intervention. The registered 731 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT03021187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03021187 about?
NCT03021187 is a clinical study titled "Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin". This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen inc...
What is the current status of trial NCT03021187?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 731 participants. The study started on 2017-02-02. Estimated completion is 2018-08-22.
What interventions are being tested in trial NCT03021187?
The interventions under investigation include: placebo (DRUG), semaglutide (DRUG).
Who is sponsoring clinical trial NCT03021187?
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 NCT03021187's enrollment target sits among peer trials
731 488th of 2000 higher than 1,512 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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