Efficacy & Safety of Liraglutide vs Lixisenatide in Type 2 Diabetes
Research type
Research Study
Full title
Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes
IRAS ID
132316
Contact name
Andrew Johnson
Contact email
Sponsor organisation
Novo Nordisk
Eudract number
2012-004984-27
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This trial is a 26-week, randomised, two armed, open label, active controlled, multicentre, multinational, parallel group trial investigating how safe and effective liraglutide 1.8 mg and lixisenatide 20 μg are as add-ons to metformin in subjects with Type 2 diabetes who have not achieved adequate glycaemic control (control of their blood sugar) on metformin.
After 2 weeks of screening, eligible subjects will be randomised (assigned to either arm of the study randomly, i.e., by chance) in a 1:1 manner to receive a once daily dose of liraglutide 1.8 mg + metformin (≥ 1000 mg/day) or lixisenatide 20 μg + metformin (≥ 1000 mg/day).
This trial will require a total of 8 visits by participating subjects at the clinic which they were recruited and a total of 3 telephone contacts. The frequency between the visits to the clinic and telephone contacts will vary between 1 and 6 weeks. The total trial participation period will be up to 29 weeks, including a 2 week screening period, 26 week treatment period and a follow-up period of 1 week.
The trial is planned to include a total of 400 randomised patients across 9 countries including the UK. In the UK there are plans to randomise 80 patients across a possible 15 sites.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0305
Date of REC Opinion
19 Aug 2013
REC opinion
Further Information Favourable Opinion