Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus Type 2, Canagliflozin, Observational Study
Brief summary
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
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.
Interventions
OTHERNo Intervention
Participants who are receiving Canagliflozin +/- other AHA as per usual clinical practice will be observed for effectiveness, safety and PRO.
Sponsors
Janssen Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months | Baseline, Month 6 and 12 | Mean HbA1c will be estimated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 7.0 Percent (%) | Month 3, 6 and 12 | Percentage of participants achieving HbA1c \<7.0 will be evaluated. |
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 6.5 Percent (%) | Month 3, 6 and 12 | Percentage of participants achieving HbA1c \<6.5 will be evaluated. |
| Change From Baseline in Mean Weight at Month 3, 6 and 12 | Baseline, Month 3, 6 and 12 | Mean Weight will be estimated. |
| Change From Baseline in Body Mass Index (BMI) at Month 3, 6 and 12 | Baseline, Month 3, 6 and 12 | The BMI will be estimated. |
| Change From Baseline in Waist Circumference at Month 3, 6 and 12 | Baseline, Month 3, 6 and 12 | Waist Circumference will be estimated. |
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 3, 6 and 12 Months by HbA1c Subgroup | Baseline, Month 3, 6 and 12 | Mean HbA1c will be estimated. |
| Percentage of Participants With Greater Than or Equal to (>=) 0.5% Reduction in Glycosylated Hemoglobin (HbA1c) Plus Weight Loss >=3% | Up to Month 12 | Percentage of participants with \>= 0.5% reduction in HbA1c plus weight loss \>=3% will be evaluated. |
| Current Health Satisfaction Questionnaire (CHES-Q) | Up to Month 12 | The responses to the questions of the CHES-Q and domain scores (physical, emotional, blood sugar, blood pressure and knowledge) will be evaluated. |
| Canagliflozin Treatment Adherence | Up to Month 12 | Treatment adherence will be based on percentage of prescribed pills taken in last 14 days as reported by participants. |
| Number of Participants with Adverse Events (AEs) and Serious AEs | Up to Month 12 | 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. |
| Percentage of Participants With Weight Loss From Baseline at Month 3, 6 and 12 | Baseline, Month 3, 6 and 12 | Percentage of participants with weight loss will be evaluated. |
Countries
Canada
Outcome results
None listed