Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

NCT02305381 · Completed

Last updated 2026-05-28

This clinical trial tested whether adding a weekly injection of semaglutide to insulin therapy (with or without metformin) 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 397 people

Who can join Ages 18+ · all sexes

Timeline Started 2014-12 · est. completion 2015-11

Where 99 sites · Germany, Japan, Puerto Rico, Serbia, Slovakia, United States

What this study is testing ClinicalTrials.gov NCT02305381 ↗

Description as written by the study sponsor.

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

Treatments tested

semaglutide Drug

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
placebo Drug

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

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

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02305381 ↗