The CANTATA-SU Trial (Canagliflozin Treatment And Trial Analysis-Sulfonylurea)

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 14.0Level: 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-BG
• Lead Sponsor: Janssen Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-11
• Last Update Posted: 16 September 2013

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:
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

• History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
•History of >1 severe hypoglycemic episodes, defined as an episode that requires the help of another person, within 6 months before screening.

Study & Design

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