Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

NCT02849080 · Completed

Last updated 2026-05-28

This clinical trial tested whether a medication called oral semaglutide, adjusted based on clinical evaluation, helps adults with type 2 diabetes better control their blood sugar compared to sitagliptin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 504 people

Who can join Ages 18+ · all sexes

Timeline Started 2016-09 · est. completion 2019-03

Where 83 sites · Argentina, Austria, Belgium, Brazil, Egypt, Norway, South Korea, Switzerland, Turkey (Türkiye), United States

What this study is testing ClinicalTrials.gov NCT02849080 ↗

Description as written by the study sponsor.

This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

Treatments tested

semaglutide Drug

Oral administration once-daily.
sitagliptin Drug

Oral administration once-daily.

Main thing measured	Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02849080 ↗