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

NCT02681497 | Completed

• 1 other identifier: 2843175DIA4018_Harris
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

canagliflozin; diabetes; SGLT2; real-world data

Outcome Measures

Primary Outcomes (1)

• change in HbA1c value

  mean change in HbA1c value at 6 months from baseline

  baseline and 6 months

Secondary Outcomes (8)

• change in weight (kg)

  baseline and 6 months

• change in blood pressure (both systolic and diastolic blood pressure)

  baseline and 6 months

• change in glomerular filtration rate

  baseline and 6 months

• change in Insulin dose

  baseline and 6 months

• Evidence of diabetic ketoacidosis documented

  within the first 6 months from baseline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Type 2DM \>18 years of age, diabetes patients on insulin who initiated Canagliflozin due to a need of tighter glycemic control .

You may not qualify if:

• glomerular filtration rate (GFR)\<45, pregnancy, type 1

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Janssen Inc.: collaborator

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stewart Harris, MD,MPH,FCFP,FACPM

  The Universtiy of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 12, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)