Phase 4
N=5,812
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2 · Albuminuria
Bottom Line
View on ClinicalTrials.gov: NCT01989754 ↗Enrolled (actual)
5,812
Serious AEs
25.6%
Results posted
Dec 2018
Primary outcome: Primary: Progression of Albuminuria — 153.01; 99.80 Events per 1000 patient-year — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Canagliflozin, 100 mg (Drug); Canagliflozin, 300 mg (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Feb 2017
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 |
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.
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). 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.