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

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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
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3000 New Bern Avenue
Raleigh, North Carolina 27610
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450 Clarkson Avenue
Brooklyn, New York 11203
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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...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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5361b North Main Street
Adairsville, Georgia 30103
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Albuquerque, New Mexico 87131
(505) 277-0111
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1085 North Harbor Boulevard
Anaheim, California 92801
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S/N Avenida Rio Verde
Aparecida De Goiânia, 74935
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13001 East 17th Place
Aurora, Colorado 80045
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Bartlett, Tennessee 38133
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Charleston, South Carolina 29407
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2001 Vail Avenue
Charlotte, North Carolina 28215
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2425 Brookstone Centre Parkway
Columbus, Georgia 31904
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65 Highview Boulevard
Columbus, Ohio 43207
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Henderson, Nevada 89014
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Kerrville, Texas 78028
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
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Miami, Florida 33174
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922 Southwest 82nd Avenue
Miami, Florida 33144
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1428 Madison Ave
New York, New York 10029
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Sacramento, California 95816
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
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Whittier, California 90603
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Wilmington, Delaware 19803
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1907 Tradd Ct
Wilmington, North Carolina 28401
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