A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus

Phase 1CompletedNCT02000700

Janssen Research & Development, LLC17 enrolled

Overview

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.

The participants who meet the eligibility criteria, will receive a single dose of placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) and this will be followed by baseline 24 hour pharmacodynamic assessments. On the next morning participants will receive the first canagliflozin dose and will be discharged home to continue canagliflozin treatment for 13 additional days. There will be 2 treatment groups (8 participants in each): the first group will receive canagliflozin 100 mg daily, the second group will receive either canagliflozin 300 mg or canagliflozin 50 mg daily. The canagliflozin dose for the second treatment group will be determined after the sponsor has evaluated the results from the first 5 participants. On day 14 of treatment the participants will be admitted again for 24 hour pharmacokinetic and pharmacodynamics assessments. The participants will continue to take their normal dose and schedule of metformin during the entire study. The total duration of the study is approximately 50 days.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin 100 mgDRUG

One 100-mg tablet of canagliflozin orally administered daily for 14 days.

Canagliflozin 50 mgDRUG

One 50-mg tablet of canagliflozin orally administered daily for 14 days.

Canagliflozin 300 mgDRUG

One 300-mg tablet of canagliflozin orally administered daily for 14 days.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (17)

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: From Days 14 to 17

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 14

Number of participants with adverse events as a measure of safety and tolerability

Time frame: Approximately 50 days

Data from ClinicalTrials.gov

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