Phase 4
Completed N=5,812
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus · Albuminuria
Source: ClinicalTrials.gov NCT01989754 ↗
Enrolled (actual)
5,812
Serious AEs
25.6%
Results posted
Dec 2018
Primary outcomePrimary: Progression of Albuminuria — 153.01; 99.80 Events per 1000 patient-year — p=<.0001
◆ Published Evidence
Established
28citations · ~14 / year
Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
Summary
The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.
Linked Publications (5)
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
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Canagliflozin may increase thromboembolic events in males with erythrocytosis but not in females.
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The Efficacy and Safety of Canagliflozin by Frailty Status in Participants of the CANVAS and CREDENCE Trials.
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A validated multivariable machine learning model to predict cardio-kidney risk in diabetic kidney disease.
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Effects of canagliflozin on total heart failure events across the kidney function spectrum: Participant-level pooled analysis from the CANVAS Program and CREDENCE trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Albuminuria |
153.01; 99.80 | <.0001 sig |
| SECONDARY Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure |
21.91; 15.85 | =0.0148 sig |
| SECONDARY Cardiovascular (CV) Death |
11.60; 10.06 | =0.4067 |
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of type 2 diabetes mellitus
- Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to =) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
- 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.
Exclusion Criteria
- History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- History of one or more severe hypoglycemic episode within 6 months before screening
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Ongoing, inadequately controlled thyroid disorder
- Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.
Data sourced from ClinicalTrials.gov (NCT01989754) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.