A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 17
Updated:3/10/2019
Start Date:July 21, 2017
End Date:June 15, 2022
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 Years) With Type 2 Diabetes Mellitus

The purpose of this study is to assess the effect of canagliflozin relative to placebo on
glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and
tolerability of canagliflozin.


Inclusion Criteria:

- Participants with a diagnosis of type 2 diabetes mellitus (T2DM)

- Random C-peptide at screening greater than (>)0.6 nanogram/milliliter (ng/mL) (>0.2
nanomole/liter [nmol]/L])

- HbA1c of greater than or equal to (>=)6.5 percent (%) to less than or equal to
(<=)10.5% and either

1. On diet and exercise alone during the 8 weeks prior to screening

2. On diet and exercise and a stable dose of metformin monotherapy >=1,000 mg per
day or MTD per day for at least 8 weeks prior to screening

3. On diet and exercise and a stable insulin monotherapy regimen for at least 8
weeks prior to screening (stable dose is defined as no change in the insulin
regimen [ie, type{s} of insulin] and <=15% change in the total daily dose of
insulin [averaged over 1 week to account for day to day variability])

4. On diet and exercise and a stable combination therapy with metformin and insulin
for at least 8 weeks prior to screening

Exclusion Criteria:

- History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or
cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or
maturity onset diabetes of the young (MODY)

- Participants on any antihyperglycemic agents (AHAs) other than metformin, or
injectable insulin within 8 weeks of the first dose of study drug (that is Day 1)

- Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose
(SMBG) measurements >270 milligram/deciliter (mg/dL) (>15 millimole/liter [mmol/L])
during the pretreatment phase, despite reinforcement of diet and exercise counseling

- Severe hypoglycemia within 6 months prior to Day 1

- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
We found this trial at
32
sites
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
5361b North Main Street
Adairsville, Georgia 30103
?
mi
from
Adairsville, GA
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1085 North Harbor Boulevard
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
S/N Avenida Rio Verde
Aparecida De Goiânia, 74935
?
mi
from
Aparecida De Goiânia,
Click here to add this to my saved trials
Apopka, Florida 32703
?
mi
from
Apopka, FL
Click here to add this to my saved trials
13001 East 17th Place
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Bartlett, Tennessee 38133
?
mi
from
Bartlett, TN
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
2001 Vail Avenue
Charlotte, North Carolina 28215
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
2425 Brookstone Centre Parkway
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
65 Highview Boulevard
Columbus, Ohio 43207
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Henderson, Nevada 89014
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Kerrville, Texas 78028
?
mi
from
Kerrville, TX
Click here to add this to my saved trials
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Miami, Florida 33174
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
922 Southwest 82nd Avenue
Miami, Florida 33144
?
mi
from
Miami, FL
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3000 New Bern Avenue
Raleigh, North Carolina 27610
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Sacramento, California 95816
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Spring Hill, Florida 34609
?
mi
from
Spring Hill, FL
Click here to add this to my saved trials
314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Whittier, California 90603
?
mi
from
Whittier, CA
Click here to add this to my saved trials
Wilmington, Delaware 19803
?
mi
from
Wilmington, DE
Click here to add this to my saved trials
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
?
mi
from
Wilmington, NC
Click here to add this to my saved trials