Liraglutide in Type 2 Diabetes and Moderate Renal Impairment

• Research type

  Research Study

• Full title

  Efficacy and safety of liraglutide versus placebo as add-on to existing diabetes medication in subjects with type 2 diabetes and moderate renal impairment A 26-week, double-blind, placebo-controlled, randomised, multicentre, multi-national, parallel-group trial

• IRAS ID

  99114

• Contact name

  Melanie Davies

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2011-002968-24

• ISRCTN Number

  na

• Research summary

  Type 2 diabetes is very often associated with renal impairment (kidney disease). Chronic kidney disease (CKD) has multiple causes. The most common cause is diabetes mellitus. CKD is found in about half of all type 2 diabetes patients consulting their GP. The presence of renal disease limits the antidiabetic treatment options available to patients. It is therefore considered highly relevant to establish efficacy and safety of new antidiabetic agents in patients with renal impairment. The rationale for this trial is to establish efficacy and safety of liraglutide as add-on to existing oral antidiabetic drugs (OADs) and/or insulin therapy in subjects with type-2 diabetes and moderate renal impairment. Liraglutide is a once-daily, human GLP-1 analogue developed by Novo Nordisk and approved for the treatment of type 2 diabetes in the EU, US and Japan under the brand name Victoza©. In total, 274 patients with type 2 diabetes and moderate renal impairment will take part in the study and receive either blinded active study medication (liraglutide) or placebo (a 'dummy' medication containing no active ingredient) in a 1:1 manner. Approximately forty (40) of the these patients will be enrolled into the study in the UK and the other countries taking part are the USA, Russia, Ukraine, Poland and France. It is expected that globally 206 patients will complete the study. Each subject's involvement in the trial will last for 29 weeks, this consists of a 2 week screening period, 26 weeks treatment period and a 1 week safety follow up period. Subjects will be asked to attend a total of 10 clinic visits and to be available for 2 telephone contacts.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  12/SC/0121

• Date of REC Opinion

  20 Apr 2012

• REC opinion

  Further Information Favourable Opinion