| Trial ID: | L5986 |
| Source ID: | NCT02000700
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| Associated Drug: |
Canagliflozin 100 Mg
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| Title: |
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Canagliflozin 100 mg|DRUG: Canagliflozin 50 mg|DRUG: Canagliflozin 300 mg|DRUG: Placebo
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| Outcome Measures: |
Primary: Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin, Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body., From Days 14 to 17 | Secondary: Plasma glucose concentration following multiple oral doses of canagliflozin, Plasma glucose is equal to the amount of glucose in the plasma at the defined time points., From Days -1 to 1, and from Days 14 to 15|Urine glucose excretion following multiple oral doses of canagliflozin, Urine glucose excretion is equal to the amount of glucose excreted into the urine over defined time intervals., From Days -1 to 1, and from Days 14 to 15|Renal threshold for glucose excretion following multiple oral doses of canagliflozin, Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine., From Days -1 to 1, and from Days 14 to 15|Acceptability of the canagliflozin tablet, A questionnaire containing 5 questions about the acceptability of the tablet (taste, smell, swallowability, residual mouth taste, and overall feeling) will be administered to the participants at the end of the treatment phase. Each question is rated using a 5 or 6-point scale. The scales comprise the following outcomes: very negative, negative, neutral, positive, and very positive. Results will be summarized descriptively., Day 14|Number of participants with adverse events as a measure of safety and tolerability, Approximately 50 days
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| Sponsor/Collaborators: |
Sponsor: Janssen Research & Development, LLC
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| Gender: |
ALL
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| Age: |
CHILD
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| Phases: |
PHASE1
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| Enrollment: |
17
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-03
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| Completion Date: |
2016-04
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| Results First Posted: |
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| Last Update Posted: |
2017-03-03
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| Locations: |
Little Rock, Arkansas, United States|Los Angeles, California, United States|Aurora, Colorado, United States|New Haven, Connecticut, United States|Jacksonville, Florida, United States|Indianapolis, Indiana, United States|Lenexa, Kansas, United States|Baltimore, Maryland, United States|Kansas City, Missouri, United States|Toledo, Ohio, United States|Pittsburgh, Pennsylvania, United States|Houston, Texas, United States|Salt Lake City, Utah, United States|Campinas, Brazil|Curitiba, Brazil|Ribeirão Preto, Brazil|Sao Paulo, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT02000700
|
