This is a study to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney functio
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2Renal Insufficiency
- Registration Number
- CTRI/2010/091/001337
- Lead Sponsor
- Janssen Research Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method