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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02688075

28431754DIA4012 (Other Identifier)

CR107542

Details and patient eligibility

About

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.

Full 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.

Enrollment: 538 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

538 participants in 1 patient group

Canagliflozin Plus or Minus(+/-) Other Antihyperglycemic Agent

Description:

Participants who are receiving Canagliflozin +/- other antihyperglycemic agent (AHA) as per usual clinical practice will be observed for effectiveness, safety and PRO.

Treatment:

Other: No Intervention