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

Diabetes Mellitus, Type 2 Clinical Trial

— CanCARE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688075
• Other study ID #: CR107542
• Secondary ID: 28431754DIA4012
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: October 27, 2017
• Start date: November 13, 2015
• Est. completion date: August 17, 2017

Study information

• Verified date: October 2017
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months	Mean HbA1c will be estimated.	Baseline, Month 6 and 12
Secondary	Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 3, 6 and 12 Months by HbA1c Subgroup	Mean HbA1c will be estimated.	Baseline, Month 3, 6 and 12
Secondary	Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 7.0 Percent (%)	Percentage of participants achieving HbA1c <7.0 will be evaluated.	Month 3, 6 and 12
Secondary	Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 6.5 Percent (%)	Percentage of participants achieving HbA1c <6.5 will be evaluated.	Month 3, 6 and 12
Secondary	Change From Baseline in Mean Weight at Month 3, 6 and 12	Mean Weight will be estimated.	Baseline, Month 3, 6 and 12
Secondary	Change From Baseline in Body Mass Index (BMI) at Month 3, 6 and 12	The BMI will be estimated.	Baseline, Month 3, 6 and 12
Secondary	Change From Baseline in Waist Circumference at Month 3, 6 and 12	Waist Circumference will be estimated.	Baseline, Month 3, 6 and 12
Secondary	Percentage of Participants With Weight Loss From Baseline at Month 3, 6 and 12	Percentage of participants with weight loss will be evaluated.	Baseline, Month 3, 6 and 12
Secondary	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.	Up to Month 12
Secondary	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.	Up to Month 12
Secondary	Canagliflozin Treatment Adherence	Treatment adherence will be based on percentage of prescribed pills taken in last 14 days as reported by participants.	Up to Month 12
Secondary	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.	Up to Month 12