INTENSE study
Research type
Research Study
Full title
Real world effectiveness of lixisenatide and other intensification therapy in the management of type 2 diabetic patients uncontrolled with basal insulin
IRAS ID
149984
Contact name
Stephen Bain
Contact email
Sponsor organisation
Sanofi-aventis R&D
Research summary
The goal of the INTENSE study is to provide an epidemiological evidence generation platform of a sample of type 2 diabetes mellitus (T2DM) patients who are uncontrolled despite basal insulin and are in need to intensify, or have recently intensified their basal insulin regimen with an injectable therapy. INTENSE is an observational non-interventional cohort study with prospective recruitment of patients in several European countries. Patients will be included in the cohort if they have initiated their first intensification therapy of basal insulin [+/- oral anti-diabetic drugs (OAD)] with an injectable [rapid acting insulin (RAI), premix insulin or glucagon-like peptide-1 receptor agonist (GLP-1 RA)] for no more than 3 months prior to study entry because of uncontrolled T2DM according to their physician’s judgement. These patients must have been treated with basal insulin for 6 months or more prior to their first intensification therapy. Recruitment will take place during usual clinical practice and will be stratified according to the first type of intensification (e.g. lixisenatide or other injectable therapies). The study recruitment will be balanced so that an equal person-time exposure for lixisenatide as other injectable therapies is obtained.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0203
Date of REC Opinion
12 May 2014
REC opinion
Further Information Favourable Opinion