Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only (PIONEER 1)
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 703 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only.
Actual Study Start Date: September 20, 2016
Actual Primary Completion Date: October 30, 2017
Actual Study Completion Date: December 8, 2017
Arm:
- Experimental: 3 mg oral semaglutide
- Experimental: 7 mg oral semaglutide
- Experimental: 14 mg oral semaglutide
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Date last updated at source | 2018-02-26 |
| Study type(s) | Interventional |
| Expected enrolment | 703 |
| Study start date | 2016-09-20 |
| Estimated primary completion date | 2017-10-30 |