Use of Canagliflozin in Conjunction With Insulin in a Real-world Setting

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

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.

• Study Type: Observational
• Enrollment (Actual): 269

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in HbA1c value	mean change in HbA1c value at 6 months from baseline	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in weight (kg)	mean change in weight at 6 months from baseline will be assessed	baseline and 6 months
change in glomerular filtration rate	mean change in glomerular filtration rate at 6 months from baseline will be assessed	baseline and 6 months
change in Insulin dose	change in Insulin dose (units) at 6 months from baseline will be assessed	baseline and 6 months
Evidence of diabetic ketoacidosis documented	Number of evidence of diabetic ketoacidosis within the first 6 months from baseline will be assessed	within the first 6 months from baseline
Evidence of genital infections documented	Evidence of genital infections within the first 6 months from baseline will be assessed	within the first 6 months from baseline
Evidence of hypoglycemia events documented	Number of hypoglycemia events documented within the first 6 months will be assessed	within the first 6 months from baseline
Evidence of urinary tract infection (UTI) documented	Evidence of urinary tract infection (UTI)s documented within the first 6 months will be assessed	within the first 6 months from baseline
change in blood pressure (both systolic and diastolic blood pressure)	mean change in blood pressure at 6 months from baseline will be assessed	baseline and 6 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Janssen Inc.
• Investigators: Principal Investigator: Stewart Harris, MD,MPH,FCFP,FACPM, The Universtiy of Western Ontario

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 6, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: diabetes; SGLT2; real-world data; canagliflozin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2843175DIA4018_Harris

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO