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Clinical trial

A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes (PIONEER 12)

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Last updated:31st Jul 2019
Identifier: NCT04017832

This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 1444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
Estimated Study Start Date: August 1, 2019
Estimated Primary Completion Date: August 11, 2021
Estimated Study Completion Date: September 13, 2021

- Experimental:
Oral semaglutide 3 mg and placebo (sitagliptin)
- Experimental: Oral semaglutide 7 mg and placebo (sitagliptin)
- Experimental: Oral semaglutide 14 mg and placebo (sitagliptin)
- Experimental: Sitagliptin 100 mg and placebo (oral semaglutide)

Category Value
Date last updated at source 2019-07-12
Study type(s) Interventional
Expected enrolment 1444
Study start date 2019-08-01
Estimated primary completion date 2021-08-11

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