Skip to main content
OpenTrials
Completed

NCT Number: NCT02688075

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months

    Time frame: Baseline, Month 6 and 12

    Mean HbA1c will be estimated.

Secondary outcomes

  1. Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 3, 6 and 12 Months by HbA1c Subgroup

    Time frame: Baseline, Month 3, 6 and 12

    Mean HbA1c will be estimated.

  2. Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 7.0 Percent (%)

    Time frame: Month 3, 6 and 12

    Percentage of participants achieving HbA1c <7.0 will be evaluated.

  3. Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 6.5 Percent (%)

    Time frame: Month 3, 6 and 12

    Percentage of participants achieving HbA1c <6.5 will be evaluated.

  4. Change From Baseline in Mean Weight at Month 3, 6 and 12

    Time frame: Baseline, Month 3, 6 and 12

    Mean Weight will be estimated.

  5. Change From Baseline in Body Mass Index (BMI) at Month 3, 6 and 12

    Time frame: Baseline, Month 3, 6 and 12

    The BMI will be estimated.

  6. Change From Baseline in Waist Circumference at Month 3, 6 and 12

    Time frame: Baseline, Month 3, 6 and 12

    Waist Circumference will be estimated.

  7. Percentage of Participants With Weight Loss From Baseline at Month 3, 6 and 12

    Time frame: Baseline, Month 3, 6 and 12

    Percentage of participants with weight loss will be evaluated.

  8. Percentage of Participants With Greater Than or Equal to (>=) 0.5% Reduction in Glycosylated Hemoglobin (HbA1c) Plus Weight Loss >=3%

    Time frame: Up to Month 12

    Percentage of participants with >= 0.5% reduction in HbA1c plus weight loss >=3% will be evaluated.

  9. Current Health Satisfaction Questionnaire (CHES-Q)

    Time frame: 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.

  10. Canagliflozin Treatment Adherence

    Time frame: Up to Month 12

    Treatment adherence will be based on percentage of prescribed pills taken in last 14 days as reported by participants.

  11. Number of Participants with Adverse Events (AEs) and Serious AEs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Inc.

Industry

Registry information

Official study 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)

Acronym: CanCARE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2016
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.