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Completed

NCT Number: NCT02681497

Use of Canagliflozin in Conjunction With Insulin 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Western University

London, Ontario, N6A 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. change in HbA1c value

    Time frame: baseline and 6 months

    mean change in HbA1c value at 6 months from baseline

Secondary outcomes

  1. change in weight (kg)

    Time frame: baseline and 6 months

    mean change in weight at 6 months from baseline will be assessed

  2. change in blood pressure (both systolic and diastolic blood pressure)

    Time frame: baseline and 6 months

    mean change in blood pressure at 6 months from baseline will be assessed

  3. change in glomerular filtration rate

    Time frame: baseline and 6 months

    mean change in glomerular filtration rate at 6 months from baseline will be assessed

  4. change in Insulin dose

    Time frame: baseline and 6 months

    change in Insulin dose (units) at 6 months from baseline will be assessed

  5. Evidence of diabetic ketoacidosis documented

    Time frame: within the first 6 months from baseline

    Number of evidence of diabetic ketoacidosis within the first 6 months from baseline will be assessed

  6. Evidence of genital infections documented

    Time frame: within the first 6 months from baseline

    Evidence of genital infections within the first 6 months from baseline will be assessed

  7. Evidence of hypoglycemia events documented

    Time frame: within the first 6 months from baseline

    Number of hypoglycemia events documented within the first 6 months will be assessed

  8. Evidence of urinary tract infection (UTI) documented

    Time frame: within the first 6 months from baseline

    Evidence of urinary tract infection (UTI)s documented within the first 6 months will be assessed

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Janssen Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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