Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006430

Trial Description

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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

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Trial Acronym

CANVAS-R

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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 will consist of a 2-week screening period and a double-blind treatment period
lasting between 78 and 156 weeks with study completion in April 2017. A total of 5,700
participants will be recruited into the study; the maximum duration of the study for each
participant can be up to 3.5 years. Participants can be either drug naïve to
antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic
therapy for the control of blood glucose levels.

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Organizational Data

  •   DRKS00006430
  •   2014/11/28
  •   2013/10/17
  •   no
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Secondary IDs

  •   2013-003050-25 
  •   NCT01989754  (ClinicalTrials.gov)
  •   CR102647  (Janssen Research & Development, LLC)
  •   2013-003050-25 
  •   28431754DIA4003 
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Health Condition or Problem studied

  •   Diabetes Mellitus, Type 2
  •   Albuminuria
  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   R80 -  Isolated proteinuria
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Interventions/Observational Groups

  •   Drug: Placebo
  •   Drug: Canagliflozin, 100 mg
  •   Drug: Canagliflozin, 300 mg
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   [---]*
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Primary Outcome

- Number of participants with progression of albuminuria; time frame: Baseline, Week 26, 52, 78, 104, 156; Progression of albuminuria is defined as the development of microalbuminuria or macroalbuminuria in a participant with baseline normoalbuminuria or the development of macroalbuminuria in a participant with baseline microalbuminuria, accompanied by an urinary albumin/creatinine ratio (ACR) value increase of greater than or equal to 30% from baseline.

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Secondary Outcome

- Number of participants with regression of albuminuria; time frame: Baseline, Week 26, 52, 78, 104, 156; Regression of albuminuria is defined as the development of normoalbuminuria in a participant with baseline microalbuminuria or macroalbuminuria, or the development of microalbuminuria in a participant with baseline macroalbuminuria, accompanied by a decrease in the urinary ACR value of greater than or equal to 30% from baseline.
- Change in estimated glomerular filtration rate (eGFR) from baseline to the last off-treatment measurement; time frame: Baseline, up to Day 30 of post treatment follow-up
- Urinary albumin/creatinine ratio at last on-treatment visit; time frame: Baseline, Week 156

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Belgium
  •   Brazil
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Korea, Republic of
  •   Malaysia
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Poland
  •   Russian Federation
  •   Spain
  •   Sweden
  •   Taiwan, Province of China
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/01/31
  •   5700
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   no maximum age
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Additional Inclusion 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 <=10.5% at screening)

- History or 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.

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Exclusion Criteria

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.

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Addresses

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    • Janssen Research & Development, LLC
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    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical Trial 
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    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.