CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 404 enrolled
Drug / intervention
liraglutide +1 moredrug
Likely dose
liraglutide 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01973231
NCT01973231Phase 4Completed
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Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Oct 31, 2013·Updated Feb 9, 2017

In Brief

A Phase 4 clinical trial evaluating liraglutide and lixisenatide for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 404 participants across 61 sites in 9 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesCzechia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 31, 2013
Enrollment StartOct 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.7 years ago

Interventions

liraglutidedrug

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).

lixisenatidedrug

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.