Use of Canagliflozin in Conjunction With Insulin in a Real-world Setting
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study is a retrospective chart review study aiming to assess the characteristics and
      health outcomes of patients with type 2 diabetes treated with canagliflozin when used in
      addition to insulin therapy. Furthermore, the project aims to establish an EMR-based cohort
      of patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin to allow for
      future longitudinal studies that investigate outcomes over a longer follow-up period, and
      whether canagliflozin (when used in addition to insulin therapy) has an impact on
      diabetes-related healthcare costs.
    

Detailed description: 
      This retrospective study will use data from an Electronic Medical Record (EMR)-based database
      (Web based Diabetes Records (Web DR) researchable database), which has been used to study
      patient's socioeconomic characteristics, treatment patterns and health outcomes of patients
      with diabetes. The Web DR de-identified researchable database contains integrated
      demographic, clinical and laboratory test result data of patients who received care from
      outpatient diabetes clinics in London, Ontario. The database includes more than 16,000
      patients and their clinic visit information since 2000.

      Adult individuals (age>=18) with type 2 diabetes receiving , registered in Web DR who have
      been treated with canagliflozin in conjunction with insulin therapy will be selected for this
      study. The baseline period will be 6 months to allow for more complete observation of
      comorbidities and medication use patterns.

      The main objective of this project is to assess the characteristics and health outcomes of
      patients with type 2 diabetes treated with canagliflozin when used in addition to insulin
      therapy.

      HbA1c, lipid, blood pressure, weight and other clinical indicators will be gathered from lab
      results during the baseline period closest to the date of canagliflozin prescription and
      follow up period (the last clinical value within the follow-up period and >=30 days after the
      start of the medication data will be selected.

      The type of insulin used and dosages prescribed during the study follow-up period will be
      extracted from the database to examine the insulin dosage prescription pattern and understand
      the use of insulin with canagliflozin and its impact on clinical outcomes.

      Furthermore, use of oral antihyperglycemic agents (metformin, sulfonylureas,
      thiazolidinedione, alpha-glucosidase inhibitors, meglitinides, Dipeptidyl peptidase-4 (DPP-4)
      inhibitors, bromocriptine) and injectable antihyperglycemic therapies (pramlintide,
      Glucagon-like peptide-1 (GLP-1) receptor agonists) will be measured during the 6 months
      baseline period and the follow-up period of 3 and 6 months.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective study will use data from an EMR-based (Web DR) researchable database,
        which has been used to study patient's socioeconomic characteristics, treatment patterns
        and health outcomes of patients with diabetes. The Web DR de-identified researchable
        database contains integrated demographic, clinical and laboratory test result data of
        patients who received care from outpatient diabetes clinics in London, Ontario. The
        database includes more than 16,000 patients and their clinic visit information since 2000.
        Adult individuals (age>=18) with type 2 diabetes registered in Web DR who have been treated
        with canagliflozin in conjunction with insulin therapy will be selected for this study.
      
Keywords: canagliflozin; diabetes; SGLT2; real-world data