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Completed

NCT Number: NCT02000700

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Campinas, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canagliflozin 100 mg

Drug

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

Canagliflozin 50 mg

Drug

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

Canagliflozin 300 mg

Drug

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

Placebo

Drug

One matching placebo tablet orally administered at baseline phase.

Primary outcomes

  1. Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin

    Time frame: From Days 14 to 17

    Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.

Secondary outcomes

  1. Plasma glucose concentration following multiple oral doses of canagliflozin

    Time frame: From Days -1 to 1, and from Days 14 to 15

    Plasma glucose is equal to the amount of glucose in the plasma at the defined time points.

  2. Urine glucose excretion following multiple oral doses of canagliflozin

    Time frame: From Days -1 to 1, and from Days 14 to 15

    Urine glucose excretion is equal to the amount of glucose excreted into the urine over defined time intervals.

  3. Renal threshold for glucose excretion following multiple oral doses of canagliflozin

    Time frame: From Days -1 to 1, and from Days 14 to 15

    Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.

  4. Acceptability of the canagliflozin tablet

    Time frame: Day 14

    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.

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

    Time frame: Approximately 50 days

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2013
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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