A Randomized, Double-Blind, Placebo and Active-Controlled, 4-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 (Canagliflozin) Compared with Sitagliptin and Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy. - The CANTATA-D Trial (CANagliflozin Treatment and Trial

• Conditions: Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy; MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2009-016525-34-EE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1260

Inclusion Criteria

Diagnosis of T2DM and be currently treated with metformin;
Patients must have inadequate diabetes control (as defined by HbA1c) at screening

Full details are included within the study protocol.

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

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 hypoglycaemic episodes within 6 months prior to screening.

Full details are included within the study protocol.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of canagliflozin relative to placebo on haemoglobin A1c after 26 weeks of treatment and assess the safety and tolerability of canagliflozin.<br> ;Secondary Objective: To assess effects of study medication on HbA1c, fasting plasma glucose (FPG), body weight, PPG, fasting plasma lipids, fasting measure of beta-cell function, systolic and diastolic blood pressure and time to rescue therapy;Primary end point(s): Change in HbA1c from baseline to week 26.<br> <br><br>