A Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy - 28431754DNE3001

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004494-28-GB

Enrollment

4200

Registered

2014-02-21

Start date

2014-07-18

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus and Diabetic Nephropathy MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Invokana Product Name: Invokana Product Code: JNJ-28431754-ZAE Pharmaceutical Form: Capsule INN or Proposed INN: CANAGLIFLOZ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -T2DM with a HbA1c = 6.5% and to = 12%, with an eGFR = 30 to 300 mg/g to = 5000 mg/g 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 2800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1400

Exclusion criteria

Exclusion criteria: - History of diabetic ketoacidosis or type 1 diabetes mellitus - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Renal disease that required treatment with immunosuppressive therapy - Known significant liver disease - Current or history of New York Heart Association (NYHA) Class IV heart failure -Blood Potassium level >5.5 millimole ( mmol) / litre (L) during screening.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): -Time to the first occurrence of an event in the primary composite endpoint ; Main Objective: In subjects with T2DM, Stage 2 or 3 CKD and macroalbuminuria who are receiving standard of care, to assess the efficacy of canagliflozin relative to placebo in reducing the composite endpoint of ESKD, doubling of serum creatinine, and renal or CV death. ; Secondary Objective: In subjects with T2DM, Stage 2 or 3 CKD and macroalbuminuria who are receiving standard of care, to assess the efficacy of canagliflozin relative to placebo in reducing: •the CV composite endpoint of CV death, non-fatal myocardial infarction (MI)MI, non-fatal stroke, hospitalized congestive heart failure, and hospitalized unstable angina • the composite endpoint of CV death and hospitalized congestive heart failure •the composite endpoint of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke (ie, 3-point major adverse cardiac event [MACE]) •Hospitalized congestive heart failure • the renal composite endpoint of ESKD, doubling of serum creatinine, and renal death •CV death • all-cause death ;Timepoint(s) of evaluation of this end point: Baseline, up to approximately Month 66	—

Measure

Time frame

Primary end point(s): -Time to the first occurrence of an event in the primary composite endpoint ; Main Objective: In subjects with T2DM, Stage 2 or 3 CKD and macroalbuminuria who are receiving standard of care, to assess the efficacy of canagliflozin relative to placebo in reducing the composite endpoint of ESKD, doubling of serum creatinine, and renal or CV death. ; Secondary Objective: In subjects with T2DM, Stage 2 or 3 CKD and macroalbuminuria who are receiving standard of care, to assess the efficacy of canagliflozin relative to placebo in reducing: •the CV composite endpoint of CV death, non-fatal myocardial infarction (MI)MI, non-fatal stroke, hospitalized congestive heart failure, and hospitalized unstable angina • the composite endpoint of CV death and hospitalized congestive heart failure •the composite endpoint of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke (ie, 3-point major adverse cardiac event [MACE]) •Hospitalized congestive heart failure • the renal composite endpoint of ESKD, doubling of serum creatinine, and renal death •CV death • all-cause death ;Timepoint(s) of evaluation of this end point: Baseline, up to approximately Month 66

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Secondary

Measure	Time frame
Secondary end point(s): -Time to the first occurrence of an event in the CV composite endpoint -Time to the first occurrence of an event in the renal composite endpoint -Time to all-cause death -Time to the first occurrence of an event in the CV Composite Endpoint of CV Death, non-fatal MI, and non-fatal stroke (ie, 3-point MACE); and Hospitalised Congestive Heart Failure -Time to CV death ;Timepoint(s) of evaluation of this end point: Baseline, up to approximately Month 66	—

Measure

Time frame

Secondary end point(s): -Time to the first occurrence of an event in the CV composite endpoint -Time to the first occurrence of an event in the renal composite endpoint -Time to all-cause death -Time to the first occurrence of an event in the CV Composite Endpoint of CV Death, non-fatal MI, and non-fatal stroke (ie, 3-point MACE); and Hospitalised Congestive Heart Failure -Time to CV death ;Timepoint(s) of evaluation of this end point: Baseline, up to approximately Month 66

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Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Guatemala, Hungary, India, Italy, Japan, Korea, Republic of, Lithuania, Malaysia, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Ukraine, United Arab Emirates, United Kingdom, United States

Contacts

Public ContactClinical Registry Group

Janssen Pharmaceutica N.V.

ClinicalTrialsEU@its.jnj.com0031 (0)71 524

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026