Patients newly diagnosed with diabetes mellitus type 2 (T2DM) are initially managed with interventions to improve diet and lifestyle, and then progress through a gradual intensification of oral and injectable hypoglycaemic agents. The newest antidiabetic drug class is the sodium glucose co-transporter 2 (SGLT2) inhibitor class (including canagliflozin). Randomized controlled trials (RCTs) showed that canagliflozin was more effective than placebo (dummy medicine) at reducing the levels of blood glucose, as measured by HbA1c, when used alone and in combination with other diabetes medicines. Canagliflozin was approved in November 2013 by the European Medicines Agency (EMA) for use in the treatment of T2DM and was launched in the United Kingdom in February 2014. This study is designed to describe the characteristics and pattern of treatment of patients with T2DM who are initiated on canagliflozin treatment, compared with patients initiated on alternative treatment options, using the CPRD data base in the United Kingdom.
This study will describe the characteristics and pattern of treatment of patients with T2DM initiated on canagliflozin compared with alternative treatment options, using the CPRD data base The study population will consist of adult T2DM patients, initiated on antidiabetic treatment and describe the treatment patterns during the study period of the most recent 5-year period available in the database at the time of the first analysis. Patient profiles at initiation and treatment patterns for canagliflozin will be compared descriptively with other antidiabetic treatments. In order to determine antidiabetic treatment patterns, prescriptions of the antidiabetic drugs will be converted into episodes of uninterrupted use. After constructing the treatment episodes of antidiabetic treatments, sequential changes will be determined, resulting in a treatment pattern. Adherence will be determined using the medication possession ratio (MPR), calculated as the number of days supplied or prescribed divided by the duration of the exposure period. The time to the first initiation of insulin/GLP1 will be estimated using a Kaplan Meier survival analysis. Comparative analyses will be conducted on the time to event endpoints Adjusted HR will be estimated, based on multivariate Cox proportional hazards models, adjusting for potential confounding related to differences in characteristics between patient cohorts.
Canagliflozin will be descriptively compared with the following antidiabetic treatments: - Sulphonylureas: glimepiride, glibenclamide and gliclazide. - DPP4: sitagliptin, saxagliptin, vildagliptin, linagliptin and alogliptin. - GLP1: exenatide (immediate release: Byetta; depot: Bydureon), liraglutide and lixisenatide - TZD: pioglitazone - SGLT2: dapagliflozin and empagliflozin; - Insulin
Pamela Gillian Hamilton - Chief Investigator - Janssen France
Pamela Gillian Hamilton - Corresponding Applicant - Janssen France
Joris Diels - Collaborator - Janssen Pharmaceutica NV