Clinical trial NCT02681497: Use of Canagliflozin in Conjunction With Insulin in a Real-world Setting
Official title: Characteristics and Health Outcomes of Patients With Type 2 Diabetes Treated With Canagliflozin Added to Insulin Therapy in a Real-world Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: canagliflozin
diabetes
SGLT2
real-world data
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Janssen Inc.
First posted: 2016-02-12
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in HbA1c value
timeFrame: baseline and 6 months
Secondary outcomes:
measure: change in weight (kg)
timeFrame: baseline and 6 months
measure: change in blood pressure (both systolic and diastolic blood pressure)
timeFrame: baseline and 6 months
measure: change in glomerular filtration rate
timeFrame: baseline and 6 months
measure: change in Insulin dose
timeFrame: baseline and 6 months
measure: Evidence of diabetic ketoacidosis documented
timeFrame: within the first 6 months from baseline
measure: Evidence of genital infections documented
timeFrame: within the first 6 months from baseline
measure: Evidence of hypoglycemia events documented
timeFrame: within the first 6 months from baseline
measure: Evidence of urinary tract infection (UTI) documented
timeFrame: within the first 6 months from baseline
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: The Universtiy of Western Ontario
name: Stewart Harris, MD,MPH,FCFP,FACPM
role: PRINCIPAL_INVESTIGATOR
References: