Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

NCT03086330 · Completed

Last updated 2026-05-28

This clinical trial tested whether adding semaglutide (a weekly injection) to a standard diabetes medication (SGLT-2 inhibitor) helps lower blood sugar levels in adults with type 2 diabetes.

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 302 people

Who can join Ages 18+ · all sexes

Timeline Started 2017-03 · est. completion 2018-08

Where 72 sites · Austria, Canada, Japan, Norway, Puerto Rico, Russia, United States

What this study is testing ClinicalTrials.gov NCT03086330 ↗

Description as written by the study sponsor.

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.

Treatments tested

Semaglutide Drug

Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
Placebo Drug

Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

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

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03086330 ↗