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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Characteristics and Health Outcomes of Patients With Type 2 Diabetes Treated With Canagliflozin Added to Insulin Therapy in a Real-world Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681497
• Other study ID #: 2843175DIA4018_Harris
• Status: Completed
• Phase: N/A
• First received: February 6, 2016
• Last updated: September 9, 2016
• Start date: March 2016
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Canada	Western University	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1c value	mean change in HbA1c value at 6 months from baseline	baseline and 6 months	No
Secondary	change in weight (kg)	mean change in weight at 6 months from baseline will be assessed	baseline and 6 months	No
Secondary	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	No
Secondary	change in glomerular filtration rate	mean change in glomerular filtration rate at 6 months from baseline will be assessed	baseline and 6 months	No
Secondary	change in Insulin dose	change in Insulin dose (units) at 6 months from baseline will be assessed	baseline and 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No