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 |
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.
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
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SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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S/N Avenida Rio Verde
Aparecida De Goiânia, 74935
Aparecida De Goiânia, 74935
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13001 East 17th Place
Aurora, Colorado 80045
Aurora, Colorado 80045
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 403-5200
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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