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

NCT02688075 | Completed

• 2 other identifiers: CR10754228431754DIA4012
• Study Type: observational
• Target: 538
• Locations: 1 country
• Sites: 23

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus Type 2; Canagliflozin; Observational Study

Outcome Measures

Primary Outcomes (1)

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

  Mean HbA1c will be estimated.

  Baseline, Month 6 and 12

Secondary Outcomes (11)

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

  Baseline, Month 3, 6 and 12

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

  Month 3, 6 and 12

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

  Month 3, 6 and 12

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

  Baseline, Month 3, 6 and 12

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

  Baseline, Month 3, 6 and 12

Study Arms (1)

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

Interventions

No Intervention OTHER

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

Canagliflozin Plus or Minus(+/-) Other Antihyperglycemic Agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Inc.: lead

Study Sites (23)

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Coquitlam, British Columbia, Canada

Location

Unknown Facility

Surrey, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

Brampton, Ontario, Canada

Location

Unknown Facility

Downsview, Ontario, Canada

Location

Unknown Facility

Guelph, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Mississauga, Ontario, Canada

Location

Unknown Facility

Ohsweken, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Smiths Falls, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Laval, Quebec, Canada

Location

Unknown Facility

Longueuil, Quebec, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Saint-Jean-sur-Richelieu, Quebec, Canada

Location

Unknown Facility

Saint-Marc-des-Carrieres, Quebec, Canada

Location

Unknown Facility

Sherbrooke, Quebec, Canada

Location

Unknown Facility

Toronto, Quebec, Canada

Location

Unknown Facility

Westmont, Quebec, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Janssen Inc. Clinical Trial

  Janssen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 23, 2016
• Study Start: November 13, 2015
• Primary Completion: August 17, 2017
• Study Completion: August 17, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

CA (23)