An Observational Study to Assess the Canagliflozin Treatment in Type 2 Diabetes Mellitus in a Usual Clinical Practice in Canada

Study Overview
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Brief Summary
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The purpose of this study is to evaluate canagliflozin use in the treatment of type 2 diabetes mellitus (T2DM) and generate evidence of its effectiveness, safety and patient-reported outcome (PRO) in a usual clinical practice in Canada.

Detailed Description
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This is a prospective, non-interventional, nation-wide, multicenter (more than one study site) study to evaluate the treatment of T2DM with canagliflozin in a usual clinical practice in Canada. Approximately 535 participants will be enrolled into this study. The planned study duration for each participant will be 12 months [plus or minus (+/-) 4 weeks], including 4 study visits in accordance with the usual clinical practice: enrollment and visits at 3, 6 and 12 months (+/- 4 weeks). Participants will primarily be observed for effectiveness, safety and PRO over an observational period of 12 months.

Official Title
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Prospective, Observational, 12-month Assessment of Canagliflozin Treatment in Type 2 Diabetes Mellitus in a Usual Clinical Practice in Canada (CANadian CAnagliflozin REgistry: CanCARE)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must have a diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) of greater than or equal to (>=) 7 percent (%) at baseline Participant must be on a stable antihyperglycemic treatment regimen for at least 30 days prior to canagliflozin initiation Participant must have estimated glomerular filtration rate (eGFR) >=60 milliliter (mL)/minute(min)/1.73 meter^2 (m^2) Must be a sodium-glucose co-transporter 2 (SGLT2) inhibitors naive participant initiating canagliflozin treatment prior to study enrollment Participant must provide a written consent for data collection by signing an ICF indicating that they understand the procedures for data collection and are willing to participate in the study Exclusion Criteria: Participants with a history of SGLT2 inhibitors use (canagliflozin, empagliflozin, dapagliflozin or any other SGLT2 inhibitor) Participants with a history of diabetic ketoacidosis (DKA), autoimmune diabetes (example, type 1 diabetes mellitus [T1DM] and latent autoimmune diabetes in adults [LADA]), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy Participants who received an investigational drug (including vaccines) within 3 months before the initiation of canagliflozin Participant who is currently enrolled or plans to enroll in an investigational study Participant who is pregnant or breastfeeding or planning to become pregnant or breast feed during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Canagliflozin Plus or Minus(+/-) Other Antihyperglycemic Agent<br>Participants who are receiving Canagliflozin +/- other antihyperglycemic agent (AHA) as per usual clinical practice will be observed for effectiveness, safety and PRO. | Other: No Intervention<br>* Participants who are receiving Canagliflozin +/- other AHA as per usual clinical practice will be observed for effectiveness, safety and PRO.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months | Mean HbA1c will be estimated. | Baseline, Month 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 3, 6 and 12 Months by HbA1c Subgroup | Mean HbA1c will be estimated. | Baseline, Month 3, 6 and 12 | 
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 7.0 Percent (%) | Percentage of participants achieving HbA1c <7.0 will be evaluated. | Month 3, 6 and 12 | 
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 6.5 Percent (%) | Percentage of participants achieving HbA1c <6.5 will be evaluated. | Month 3, 6 and 12 | 
| Change From Baseline in Mean Weight at Month 3, 6 and 12 | Mean Weight will be estimated. | Baseline, Month 3, 6 and 12 | 
| Change From Baseline in Body Mass Index (BMI) at Month 3, 6 and 12 | The BMI will be estimated. | Baseline, Month 3, 6 and 12 | 
| Change From Baseline in Waist Circumference at Month 3, 6 and 12 | Waist Circumference will be estimated. | Baseline, Month 3, 6 and 12 | 
| Percentage of Participants With Weight Loss From Baseline at Month 3, 6 and 12 | Percentage of participants with weight loss will be evaluated. | Baseline, Month 3, 6 and 12 | 
| Percentage of Participants With Greater Than or Equal to (>=) 0.5% Reduction in Glycosylated Hemoglobin (HbA1c) Plus Weight Loss >=3% | Percentage of participants with >= 0.5% reduction in HbA1c plus weight loss >=3% will be evaluated. | Up to Month 12 | 
| Current Health Satisfaction Questionnaire (CHES-Q) | The responses to the questions of the CHES-Q and domain scores (physical, emotional, blood sugar, blood pressure and knowledge) will be evaluated. | Up to Month 12 | 
| Canagliflozin Treatment Adherence | Treatment adherence will be based on percentage of prescribed pills taken in last 14 days as reported by participants. | Up to Month 12 | 
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus Type 2, Canagliflozin, Observational Study