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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA4012 | Other Identifier | Janssen Inc. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin Plus or Minus(+/-) Other Antihyperglycemic Agent | Participants who are receiving Canagliflozin +/- other antihyperglycemic agent (AHA) as per usual clinical practice will be observed for effectiveness, safety and PRO. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | Participants who are receiving Canagliflozin +/- other AHA as per usual clinical practice will be observed for effectiveness, safety and PRO. |
|
| 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 |
| 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 (%) |
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Inclusion Criteria:
Exclusion Criteria:
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The registry population will include Canadian sodium-glucose co-transporter 2 (SGLT2) naive type 2 diabetes mellitus (T2DM) participants, initiating canagliflozin as part of their optimal treatment approach, based on the independent clinical judgment of their treating physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Inc. Clinical Trial | Janssen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary | Alberta | Canada | ||||
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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 |
| Edmonton |
| Alberta |
| Canada |
| Coquitlam | British Columbia | Canada |
| Surrey | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Brampton | Ontario | Canada |
| Downsview | Ontario | Canada |
| Guelph | Ontario | Canada |
| London | Ontario | Canada |
| Mississauga | Ontario | Canada |
| Ohsweken | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Smiths Falls | Ontario | Canada |
| Toronto | Ontario | Canada |
| Laval | Quebec | Canada |
| Longueuil | Quebec | Canada |
| Montreal | Quebec | Canada |
| Saint-Jean-sur-Richelieu | Quebec | Canada |
| Saint-Marc-des-Carrieres | Quebec | Canada |
| Sherbrooke | Quebec | Canada |
| Toronto | Quebec | Canada |
| Westmont | Quebec | Canada |
| Saskatoon | Saskatchewan | Canada |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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