Trials / Completed
CompletedNCT03021187
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 731 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | semaglutide | Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment |
| DRUG | semaglutide | Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment |
| DRUG | semaglutide | Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment |
| DRUG | placebo | Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment |
Timeline
- Start date
- 2017-02-02
- Primary completion
- 2018-01-18
- Completion
- 2018-08-22
- First posted
- 2017-01-13
- Last updated
- 2020-03-02
- Results posted
- 2019-11-07
Locations
118 sites across 10 countries: United States, Canada, France, Greece, India, Japan, Mexico, Poland, Puerto Rico, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03021187. Inclusion in this directory is not an endorsement.