An Efficacy, Safety and Tolerability Study of Canagliflozin in Patients with Type 2 Diabetes Mellitus With Potential Cardiovascular Risk Factors

Phase 1

• Conditions: Type 2 diabetes mellitus and history or high risk cardiovascular disease; MedDRA version: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; MedDRA version: 18.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-012140-16-EE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-13
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

• Patients must have a diagnosis of T2DM and a history of or a high risk for CV disease
• Patients must have inadequate diabetes control (as defined by HbA1c greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs
• Diagnosis of T2DM with a history of or at high risk for CV disease
• Patients must have inadequate diabetes control (as defined by HbA1c) at screening
Full details are included within the CANVAS study protocol.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1350

Exclusion Criteria

• A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on cardiovascular (CV) risk when used in the treatment of patients with type 2 diabetes mellitus (T2DM). Other objectives include<br>evaluating the effectiveness of canagliflozin.;Secondary Objective: To assess effects on beta-cell function, progression of albuminuria, renal function and glycemic efficacy.;Primary end point(s): Time to first occurrence of a major adverse cardiovascular event (including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke);Timepoint(s) of evaluation of this end point: Baseline, time to event (up to April 2017)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Change from Baseline in homeostasis model assessment<br>(HOMA)<br>2) Percentage of patients with progression of albuminuria <br>3) Change in glycosylated hemoglobin (HbA1c) from Baseline to Week 18 ;Timepoint(s) of evaluation of this end point: 1 and 2) Baseline, up to end of treatment (up to April 2017)<br>3) Day 1 (Baseline) to Week 18