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Diabetes Mellitus, Type 2CanCARENCT02688075

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

An observational study of Diabetes Mellitus, Type 2, run by Janssen Inc. at 23 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
How many people
538 participants
Where
23 sitesCanada
Study dates
13 Nov 2015to 17 Aug 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

23 sites in 1 country.

23 sites in 1 country

Canada23 sites

  • Study site

    Brampton, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Coquitlam, British Columbia

  • Study site

    Downsview, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Guelph, Ontario

  • Study site

    Laval, Quebec

  • Study site

    London, Ontario

  • Study site

    Longueuil, Quebec

  • Study site

    Mississauga, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ohsweken, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Saint-Jean-sur-Richelieu, Quebec

  • Study site

    Saint-Marc-des-Carrieres, Quebec

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Sherbrooke, Quebec

  • Study site

    Smiths Falls, Ontario

  • Study site

    Surrey, British Columbia

  • Study site

    Toronto, Ontario

  • Study site

    Toronto, Quebec

  • Study site

    Westmont, Quebec

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

About this study

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)

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.

Read the 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.

Being tested
No Intervention
Keywords
Diabetes Mellitus Type 2, Canagliflozin, Observational Study
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

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

Study groups in NCT02688075
Study groupRoleWhat they receive
Canagliflozin Plus or Minus(+/-) Other Antihyperglycemic AgentParticipants who are receiving Canagliflozin +/- other antihyperglycemic agent (AHA) as per usual clinical practice will be observed for effectiveness, safety and PRO.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Mean HbA1c will be estimated.

    Measured: Baseline, Month 6 and 12

Secondary outcomes (11)

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

    Mean HbA1c will be estimated.

    Measured: Baseline, Month 3, 6 and 12

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

    Percentage of participants achieving HbA1c <7.0 will be evaluated.

    Measured: Month 3, 6 and 12

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

    Percentage of participants achieving HbA1c <6.5 will be evaluated.

    Measured: Month 3, 6 and 12

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

    Mean Weight will be estimated.

    Measured: Baseline, Month 3, 6 and 12

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

    The BMI will be estimated.

    Measured: Baseline, Month 3, 6 and 12

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

    Waist Circumference will be estimated.

    Measured: Baseline, Month 3, 6 and 12

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

    Percentage of participants with weight loss will be evaluated.

    Measured: Baseline, Month 3, 6 and 12

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

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

    Measured: Up to Month 12

  9. Current Health Satisfaction Questionnaire (CHES-Q)

    The responses to the questions of the CHES-Q and domain scores (physical, emotional, blood sugar, blood pressure and knowledge) will be evaluated.

    Measured: Up to Month 12

  10. Canagliflozin Treatment Adherence

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

    Measured: Up to Month 12

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

    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.

    Measured: Up to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2016 (estimated)
  2. Study start13 Nov 2015
  3. Primary completion17 Aug 2017
  4. Study completion17 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02688075
Sponsor's protocol ID
CR107542
Other IDs
28431754DIA4012
Acronym
CanCARE
Status last verified
Oct 2017
First submitted
17 Feb 2016
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Janssen Inc. at 23 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months (time frame: Baseline, Month 6 and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688075.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.

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