Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

NCT01930188 · Completed

Last updated 2026-05-28

This clinical trial tested once-weekly semaglutide compared to once-daily sitagliptin, both added to metformin and/or a thiazolidinedione, in adults with type 2 diabetes to see how they affected blood sugar levels over time.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 1,231 people

Who can join Ages 18+ · all sexes

Timeline Started 2013-12 · est. completion 2015-10

Where 141 sites · Argentina, Bulgaria, Czechia, Hong Kong, Hungary, India, Japan, Mexico, Norway, Portugal, Romania, Russia, South Africa, Spain, Sweden, Thailand, Turkey (Türkiye), Ukraine

What this study is testing ClinicalTrials.gov NCT01930188 ↗

Description as written by the study sponsor.

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.

Treatments tested

semaglutide Drug

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
sitagliptin Drug

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
placebo Drug

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
placebo Drug

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Main thing measured	Change in HbA1c (Glycosylated Haemoglobin) From Baseline
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01930188 ↗