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

Sponsor
Novo Nordisk A/S
Study ID
NCT01973231
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Oct 31, 2013
Status verified
Dec 2016
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

Enrollment
404 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin + liraglutide 1.8 mg
  • Active Comparator: Metformin + lixisenatide 20 microg

Primary Outcome Measure

Change in Glycosylated Haemoglobin (HbA1c) From Baseline [ Time Frame: Week 0, week 26 ]

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