CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-009320-36-DE
• Lead Sponsor: Janssen Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-02
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1281

Inclusion Criteria

•Diagnosis of T2DM;
•Taking a stable dosage of metformin at screening.

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 897
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 384

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.

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 glimepiride on haemoglobin A1c after 52 weeks of treatment.;Secondary Objective: To assess effects of study medication on body weight, incidence of hypoglycaemia, systolic and diastolic blood pressure, fasting plasma glucose (FPG) and HbA1c.;Primary end point(s): The primary efficacy endpoint will be the change in HbA1c. ;Timepoint(s) of evaluation of this end point: From baseline through Week 52.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint is percent change in body weight ;Timepoint(s) of evaluation of this end point: From baseline through Week 52.