An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

• Conditions: Type 2 Diabetes Mellitus with Moderate Renal Impairment; MedDRA version: 14.0Level: PTClassification code 10062237Term: Renal impairmentSystem Organ Class: 10038359 - Renal and urinary disorders; 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: EUCTR2009-017136-40-PL
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-19
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

•Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents)
•Patients with reduced kidney function
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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

Exclusion Criteria

•History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
•Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
•Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
•Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen
•History of a severe hypoglycemic episode within 6 months before screening

Study & Design

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