Type 2 Diabetes Mellitus Clinical Trial
Official title:
Characteristics and Health Outcomes of Patients With Type 2 Diabetes Treated With Canagliflozin Added to Insulin Therapy in a Real-world Setting
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.
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.
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Observational Model: Cohort, Time Perspective: Retrospective
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