An Observational Study to Assess the Canagliflozin Treatment in Type 2 Diabetes Mellitus in a Usual Clinical Practice in Canada
NCT ID: NCT02688075
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
538 participants
OBSERVATIONAL
2015-11-13
2017-08-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No Intervention
Participants who are receiving Canagliflozin +/- other AHA as per usual clinical practice will be observed for effectiveness, safety and PRO.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No Intervention
Participants who are receiving Canagliflozin +/- other AHA as per usual clinical practice will be observed for effectiveness, safety and PRO.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Inc. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Coquitlam, British Columbia, Canada
Surrey, British Columbia, Canada
Winnipeg, Manitoba, Canada
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
Laval, Quebec, Canada
Longueuil, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jean-sur-Richelieu, Quebec, Canada
Saint-Marc-des-Carrieres, Quebec, Canada
Sherbrooke, Quebec, Canada
Toronto, Quebec, Canada
Westmont, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
28431754DIA4012
Identifier Type: OTHER
Identifier Source: secondary_id
CR107542
Identifier Type: -
Identifier Source: org_study_id