A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Endocrine, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - Any
Updated:12/13/2018
Start Date:January 16, 2014
End Date:February 23, 2017

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

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

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.

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.

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.
We found this trial at
61
sites
?
mi
from
Draper, UT
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Beaver, PA
Click here to add this to my saved trials
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Canal Fulton, OH
Click here to add this to my saved trials
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Concord, CA
Click here to add this to my saved trials
?
mi
from
Cornelius, NC
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Elkridge, MD
Click here to add this to my saved trials
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
?
mi
from
Flint, MI
Click here to add this to my saved trials
420 West 12th Avenue
Franklin, Ohio 43210
?
mi
from
Franklin, OH
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jefferson City, Tennessee 37760
?
mi
from
Jefferson City, TN
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
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Levittown, PA
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
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Mandeville, LA
Click here to add this to my saved trials
?
mi
from
Mason, OH
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Metairie, LA
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, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Mooresville, North Carolina 28117
?
mi
from
Mooresville, NC
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Norristown, PA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Opa-locka, FL
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Pearland, TX
Click here to add this to my saved trials
?
mi
from
Picayune, MS
Click here to add this to my saved trials
?
mi
from
Pismo Beach, CA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
South Burlington, Vermont 05403
?
mi
from
South Burlington, VT
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Thousand Oaks, California 91360
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
?
mi
from
Tipton, PA
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
?
mi
from
Valparaiso, IN
Click here to add this to my saved trials
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
?
mi
from
Washington, MO
Click here to add this to my saved trials
?
mi
from
Wauwatosa, WI
Click here to add this to my saved trials
?
mi
from
West Jordan, UT
Click here to add this to my saved trials