Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

NCT01973231 · Completed

Last updated 2026-05-28

This clinical trial compared the effects of two diabetes medications, liraglutide and lixisenatide, when added to metformin in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

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

Participants 404 people

Who can join Ages 18+ · all sexes

Timeline Started 2013-10 · est. completion 2014-11

Where 61 sites · Czechia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, United Kingdom

What this study is testing ClinicalTrials.gov NCT01973231 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).

Treatments tested

liraglutide Drug

Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day).
lixisenatide Drug

Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.

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

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01973231 ↗