A study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus

Phase 1

• Conditions: Patients with type 2 diabetes mellitus (T2DM) receiving standard of care but with inadequate glycemic control and at elevated risk of cardiovascular (CV) events; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-003050-25-IT
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-25
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5700

Inclusion Criteria

1. Must have a diagnosis of type 2 diabetes mellitus.
2. Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening)
3. History or high risk of CV events.
4. Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels.
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 3420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2280

Exclusion Criteria

1. History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
2. History of one or more severe hypoglycemic episode within 6 months before screening.
3. History of hereditary glucose-galactose malabsorption or primary renal glucosuria.
4. Ongoing, inadequately controlled thyroid disorder.
5. Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
6. Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To assess the effect of canagliflozin compared to placebo on progression of albuminuria.;Secondary Objective: To assess the effect of canagliflozin compared to placebo on:<br>1. Regression of albuminuria<br>2. Estimated glomerular filtration rate (eGFR)<br>3. Urinary albumin/creatinine ratio;Primary end point(s): 1. Number of participants with progression of albuminuria;Timepoint(s) of evaluation of this end point: 1. Baseline, Week 26, 52, 78, 104, 156

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Number of participants with regression of albuminuria<br>2. Change in estimated glomerular filtration rate (eGFR) from baseline to the last off-treatment measurement.<br>3. Urinary albumin/creatinine ratio at last on-treatment visit;Timepoint(s) of evaluation of this end point: 1. Baseline, Week 26, 52, 78, 104, 156<br>2. Baseline, up to Day 30 of post treatment follow-up<br>3. Baseline, Week 156