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

Phase 1

• Conditions: Type 2 Diabetes Mellitus with Moderate Renal Impairment; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0Level: PTClassification code 10062237Term: Renal impairmentSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-017136-40-BE
• Lead Sponsor: Janssen Cilag international NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-15
• Last Update Posted: 21 August 2017

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
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combination therapy (including oral or non oral agents)
•Patients with reduced kidney function

For complete listing, refer to section 4.2 in the 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 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

For complete listing, refer to section 4.3 in the protocol.

Study & Design

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