A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus
Open-Label, Multicenter, Multiple Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents ≥10 to <18 Years of Age With Type 2 Diabetes Mellitus and Currently on a Stable Dose of Metformin
2 other identifiers
interventional
17
2 countries
17
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics (blood levels) and pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other purposes are to investigate safety and assess the ease of swallowing the tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus-type-2
Started Mar 2014
Longer than P75 for phase_1 diabetes-mellitus-type-2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMarch 3, 2017
February 1, 2017
2.1 years
November 27, 2013
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Plasma glucose concentration following multiple oral doses of canagliflozin
From Days -1 to 1, and from Days 14 to 15
Urine glucose excretion following multiple oral doses of canagliflozin
From Days -1 to 1, and from Days 14 to 15
Renal threshold for glucose excretion following multiple oral doses of canagliflozin
From Days -1 to 1, and from Days 14 to 15
Acceptability of the canagliflozin tablet
Day 14
Number of participants with adverse events as a measure of safety and tolerability
Approximately 50 days
Study Arms (2)
Canagliflozin (Dose Group 1)
EXPERIMENTALParticipants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days.
Canagliflozin (Dose Group 2)
EXPERIMENTALParticipants will be enrolled into Dose Group 2 to receive either 50 mg (as 1 x 50-mg tablet) or 300 mg (as 1 x 300-mg tablet) of canagliflozin daily for 14 days.
Interventions
One 100-mg tablet of canagliflozin orally administered daily for 14 days.
One 50-mg tablet of canagliflozin orally administered daily for 14 days.
One 300-mg tablet of canagliflozin orally administered daily for 14 days.
One matching placebo tablet orally administered at baseline phase.
Eligibility Criteria
You may qualify if:
- Diagnosed with Type 2 Diabetes Mellitus
- Be on a stable regimen of metformin immediate release (IR) monotherapy of at least 1,000 mg/day for at least 8 weeks before screening
- Able to swallow whole tablets
- Absence of pancreatic autoimmunity
- Participants and their caregivers must agree to perform the fasting fingerstick glucose self-monitoring during the study
You may not qualify if:
- History of Type 1 diabetes mellitus
- History of maturity onset diabetes of the young (MODY) and any secondary form of diabetes
- Current clinically significant medical illness e.g., significant pulmonary disease, renal or hepatic insufficiency, uncontrolled thyroid disease
- Systolic or diastolic blood pressure outside the range considered normal for the participant sex, age and height
- For females, participants will be excluded if pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Lenexa, Kansas, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Campinas, Brazil
Unknown Facility
Curitiba, Brazil
Unknown Facility
Ribeirão Preto, Brazil
Unknown Facility
São Paulo, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 4, 2013
Study Start
March 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
March 3, 2017
Record last verified: 2017-02