A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R)
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| ClinicalTrials.gov Identifier: NCT01989754 |
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Recruitment Status :
Completed
First Posted : November 21, 2013
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 Albuminuria | Drug: Placebo Drug: Canagliflozin, 100 mg Drug: Canagliflozin, 300 mg | Phase 4 |
The study will be conducted in adult participants with Type 2 Diabetes Mellitus (T2DM), receiving standard of care for hyperglycemia and cardiovascular (CV) risk factors, who have either a history of a prior CV event or 2 or more risk factors for a CV event. Participants will be randomly assigned in a 1:1 ratio to canagliflozin or matching placebo to be taken once daily. Canagliflozin will be provided at a dose of 100 mg/day through Week 13 and then increased at the discretion of the investigator to a dose of 300 mg/day, if the participant requires additional glycemic control and is tolerating the 100 mg dose.
The study consists of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks; study completion is targeted for when the last subject randomized has approximately 78 weeks of follow-up or when 688 major adverse cardiovascular events are accumulated between CANVAS and CANVAS-R. A total of 5,700 participants are targeted to be recruited into the study. Participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels.
The completion target was reached in February 2017.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5813 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus |
| Actual Study Start Date : | January 16, 2014 |
| Actual Primary Completion Date : | February 23, 2017 |
| Actual Study Completion Date : | February 23, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Canagliflozin (JNJ-28431754)
Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 13 weeks, then the dose may be increased to 300 mg once daily.
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Drug: Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily Drug: Canagliflozin, 300 mg One 300 mg capsule taken orally (by mouth) once daily |
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Placebo Comparator: Placebo
Each patient will receive placebo (inactive medication) once daily.
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Drug: Placebo
One placebo capsule taken orally (by mouth) once daily for 156 weeks |
- Progression of Albuminuria [ Time Frame: Up to 3 years ]Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio [UACR] 30 to 300 milligram per gram [mg/g]) or macroalbuminuria (Albumin/creatinine ratio [ACR] of greater than [>] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than [<] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event.
- Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure [ Time Frame: Approximately 3 years ]Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
- Cardiovascular (CV) Death [ Time Frame: Approximately 3 years ]Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 <=10.5% at screening)
- Greater than or equal 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989754
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| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Documents provided by Janssen Research & Development, LLC:
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01989754 |
| Other Study ID Numbers: |
CR102647 2013-003050-25 ( EudraCT Number ) 28431754DIA4003 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | November 21, 2013 Key Record Dates |
| Results First Posted: | December 11, 2018 |
| Last Update Posted: | December 11, 2018 |
| Last Verified: | November 2018 |
| Studies a U.S. FDA-regulated Device Product: | No |
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Albuminuria Canagliflozin Cardiovascular outcomes Type 2 Diabetes Mellitus |
T2DM JNJ-28431754 Antihyperglycemic Agent |
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Albuminuria Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Proteinuria Urination Disorders Urologic Diseases Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Urological Manifestations Canagliflozin Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |