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

NCT ID: NCT02681497

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 269 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-07-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Inc.

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Stewart Harris

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stewart Harris, MD,MPH,FCFP,FACPM

Role: PRINCIPAL_INVESTIGATOR

The Universtiy of Western Ontario

Locations

Western University

London, Ontario, Canada

Countries

Canada

Other Identifiers

2843175DIA4018_Harris

Identifier Type: -

Identifier Source: org_study_id