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

• Sponsor: Janssen Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02688075
• Collaborator: (none)
• Enrollment: 538
• Locations: 23
• Actual Duration (Months): 21.1
• Patients Per Site: 23.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Nov 13, 2015
• Actual Primary Completion Date: Aug 17, 2017
• Actual Study Completion Date: Aug 17, 2017

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at 6 and 12 Months [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 [Baseline, Month 3, 6 and 12]

   Mean HbA1c will be estimated.

2. Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than (<) 7.0 Percent (%) [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 (%) [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 [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 [Baseline, Month 3, 6 and 12]

   The BMI will be estimated.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Calgary	Alberta	Canada
2		Edmonton	Alberta	Canada
3		Coquitlam	British Columbia	Canada
4		Surrey	British Columbia	Canada
5		Winnipeg	Manitoba	Canada
6		Brampton	Ontario	Canada
7		Downsview	Ontario	Canada
8		Guelph	Ontario	Canada
9		London	Ontario	Canada
10		Mississauga	Ontario	Canada
11		Ohsweken	Ontario	Canada
12		Ottawa	Ontario	Canada
13		Smiths Falls	Ontario	Canada
14		Toronto	Ontario	Canada
15		Laval	Quebec	Canada
16		Longueuil	Quebec	Canada
17		Montreal	Quebec	Canada
18		Saint-Jean-Sur-Richelieu	Quebec	Canada
19		Sherbrooke	Quebec	Canada
20		St Marc Des Carrieres	Quebec	Canada
21		Toronto	Quebec	Canada
22		Westmont	Quebec	Canada
23		Saskatoon	Saskatchewan	Canada

Sponsors and Collaborators

• Janssen Inc.

Investigators

• Study Director: Janssen Inc. Clinical Trial, Janssen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Inc.
• ClinicalTrials.gov Identifier: NCT02688075
• Other Study ID Numbers: CR107542; 28431754DIA4012
• First Posted: Feb 23, 2016
• Last Update Posted: Oct 30, 2017
• Last Verified: Oct 1, 2017

• 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: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 30, 2017