Clinical trial NCT02688075: An Observational Study to Assess the Canagliflozin Treatment in Type 2 Diabetes Mellitus in a Usual Clinical Practice in Canada
Official title: Prospective, Observational, 12-month Assessment of Canagliflozin Treatment in Type 2 Diabetes Mellitus in a Usual Clinical Practice in Canada (CANadian CAnagliflozin REgistry: CanCARE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus Type 2
Canagliflozin
Observational Study
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months
timeFrame: Baseline, Month 6 and 12
Secondary outcomes:
measure: Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 3, 6 and 12 Months by HbA1c Subgroup
timeFrame: Baseline, Month 3, 6 and 12
measure: Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 7.0 Percent (%)
timeFrame: Month 3, 6 and 12
measure: Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 6.5 Percent (%)
timeFrame: Month 3, 6 and 12
measure: Change From Baseline in Mean Weight at Month 3, 6 and 12
timeFrame: Baseline, Month 3, 6 and 12
measure: Change From Baseline in Body Mass Index (BMI) at Month 3, 6 and 12
timeFrame: Baseline, Month 3, 6 and 12
measure: Change From Baseline in Waist Circumference at Month 3, 6 and 12
timeFrame: Baseline, Month 3, 6 and 12
measure: Percentage of Participants With Weight Loss From Baseline at Month 3, 6 and 12
timeFrame: Baseline, Month 3, 6 and 12
measure: Percentage of Participants With Greater Than or Equal to (>=) 0.5% Reduction in Glycosylated Hemoglobin (HbA1c) Plus Weight Loss >=3%
timeFrame: Up to Month 12
measure: Current Health Satisfaction Questionnaire (CHES-Q)
timeFrame: Up to Month 12
measure: Canagliflozin Treatment Adherence
timeFrame: Up to Month 12
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Coquitlam
country: Canada
state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Brampton
country: Canada
state: Ontario
city: Downsview
country: Canada
state: Ontario
city: Guelph
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Ohsweken
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Smiths Falls
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Longueuil
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saint-Jean-Sur-Richelieu
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St Marc Des Carrieres
country: Canada
state: Quebec
city: Toronto
country: Canada
state: Quebec
city: Westmont
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: