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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688075
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: No Intervention

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.

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Study Type : Observational
Actual Enrollment : 538 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : November 13, 2015
Actual Primary Completion Date : August 17, 2017
Actual Study Completion Date : August 17, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: No Intervention
Participants who are receiving Canagliflozin +/- other AHA as per usual clinical practice will be observed for effectiveness, safety and PRO.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688075


Locations
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Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Coquitlam, British Columbia, Canada
Surrey, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
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
Canada, Quebec
Laval, Quebec, Canada
Longueuil, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jean-Sur-Richelieu, Quebec, Canada
Sherbrooke, Quebec, Canada
St Marc Des Carrieres, Quebec, Canada
Toronto, Quebec, Canada
Westmont, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Janssen Inc.
Investigators
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Study Director: Janssen Inc. Clinical Trial Janssen Inc.

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Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT02688075    
Other Study ID Numbers: CR107542
28431754DIA4012 ( Other Identifier: Janssen Inc. )
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Janssen Inc.:
Diabetes Mellitus Type 2
Canagliflozin
Observational Study
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs