Type 2 Diabetes Mellitus
Conditions
Keywords
canagliflozin, diabetes, SGLT2, real-world data
Brief 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.
Interventions
None listed
Sponsors
Janssen Inc.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Type 2DM \>18 years of age, diabetes patients on insulin who initiated Canagliflozin due to a need of tighter glycemic control .
Exclusion criteria
* glomerular filtration rate (GFR)\<45, pregnancy, type 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in HbA1c value | baseline and 6 months | mean change in HbA1c value at 6 months from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in blood pressure (both systolic and diastolic blood pressure) | baseline and 6 months | mean change in blood pressure at 6 months from baseline will be assessed |
| change in glomerular filtration rate | baseline and 6 months | mean change in glomerular filtration rate at 6 months from baseline will be assessed |
| change in Insulin dose | baseline and 6 months | change in Insulin dose (units) at 6 months from baseline will be assessed |
| change in weight (kg) | baseline and 6 months | mean change in weight at 6 months from baseline will be assessed |
| Evidence of genital infections documented | within the first 6 months from baseline | Evidence of genital infections within the first 6 months from baseline will be assessed |
| Evidence of hypoglycemia events documented | within the first 6 months from baseline | Number of hypoglycemia events documented within the first 6 months will be assessed |
| Evidence of urinary tract infection (UTI) documented | within the first 6 months from baseline | Evidence of urinary tract infection (UTI)s documented within the first 6 months will be assessed |
| Evidence of diabetic ketoacidosis documented | within the first 6 months from baseline | Number of evidence of diabetic ketoacidosis within the first 6 months from baseline will be assessed |
Countries
Canada
Outcome results
None listed