Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy



Status:Completed
Conditions:Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:30 - Any
Updated:1/27/2019
Start Date:February 17, 2014
End Date:October 30, 2018

Use our guide to learn which trials are right for you!

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

The goal of this study is to assess whether canagliflozin has a renal and vascular protective
effect in reducing the progression of renal impairment relative to placebo in participants
with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and
macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled
daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor
blocker (ARB).

This is a randomized (the study medication is assigned by chance), double-blind (neither
physician nor participant knows the identity of the assigned treatment), placebo-controlled
(an inactive substance that is compared with a medication to test whether the medication has
a real effect), parallel-group, multicenter study of the effects of canagliflozin on renal
and cardiovascular outcomes in participants with type 2 diabetes mellitus (T2DM) and diabetic
nephropathy, who are receiving standard of care including a maximum tolerated daily dose of
an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

The study will consist of a pretreatment phase (several weeks), and a double-blind treatment
phase (up to approximately 66 months). During the pretreatment phase all participants will
also receive diet/exercise counseling for lipid and blood pressure management as well as
counseling on renal and cardiovascular (CV) risk factor medication. A post-treatment
follow-up contact or visit will take place approximately 30 days after the last dose of study
drug or the completion of the study. The total duration of the study is estimated to be about
5 to 5.5 years. Approximately 4,200 participants will be randomized in a 1:1 ratio to
canagliflozin or matching placebo. Participants randomized to canagliflozin will receive a
dose of 100 mg once daily. The overall safety and tolerability of canagliflozin will be
evaluated by collecting information on adverse events, laboratory tests, vital signs (pulse,
blood pressure), physical examination, and body weight.

Inclusion Criteria:

- Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=)
6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular
filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less
than (<) 90 mL/min/1.73 m^2

- Participants need to be on a stable maximum tolerated labeled daily dose of an
angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
for at least 4 weeks prior to randomization

- Must have a urine albumin to creatinine ratio (UACR) of greater than (>) 300 milligram
(mg)/gram (g) and <= 5000 mg/g

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)/liter (L) during Screening
We found this trial at
153
sites
?
mi
from
Schertz, TX
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Bahía Blanca,
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Beaver, PA
Click here to add this to my saved trials
?
mi
from
Beltsville, MD
Click here to add this to my saved trials
?
mi
from
Bennington, VT
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bluefield, VA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Calabash, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Corsicana, TX
Click here to add this to my saved trials
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
?
mi
from
Covina, CA
Click here to add this to my saved trials
?
mi
from
Crystal Lake, IL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
?
mi
from
Downey, CA
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
?
mi
from
Edinburg, TX
Click here to add this to my saved trials
?
mi
from
Flint, MI
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
?
mi
from
Fremont, NE
Click here to add this to my saved trials
?
mi
from
Golden, CO
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
?
mi
from
Gurnee, IL
Click here to add this to my saved trials
?
mi
from
Hawthorne, CA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington, West Virginia 25701
?
mi
from
Huntington, WV
Click here to add this to my saved trials
?
mi
from
Hyattsville, MD
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Inglewood, CA
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Kenner, LA
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Lakewood, CA
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
Lancaster, South Carolina 29720
?
mi
from
Lancaster, SC
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Lynwood, CA
Click here to add this to my saved trials
?
mi
from
Maumee, OH
Click here to add this to my saved trials
?
mi
from
Mechanicsville, VA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Merrillville, IN
Click here to add this to my saved trials
?
mi
from
Mesquite, TX
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
?
mi
from
Michigan City, IN
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
?
mi
from
Morganton, NC
Click here to add this to my saved trials
?
mi
from
Mount Prospect, IL
Click here to add this to my saved trials
?
mi
from
Muncie, IN
Click here to add this to my saved trials
?
mi
from
Murrells Inlet, SC
Click here to add this to my saved trials
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Northridge, CA
Click here to add this to my saved trials
?
mi
from
Oakland, CA
Click here to add this to my saved trials