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

March 1, 2017 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
      • Ribeirão Preto, Brazil
      • Sao Paulo, Brazil
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Los Angeles, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Florida
      • Jacksonville, Florida, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Lenexa, Kansas, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Ohio
      • Toledo, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Texas
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canagliflozin (Dose Group 1)
Participants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days.
Drug: Canagliflozin 100 mg
One 100-mg tablet of canagliflozin orally administered daily for 14 days.
Drug: Placebo
One matching placebo tablet orally administered at baseline phase.
Experimental: Canagliflozin (Dose Group 2)
Participants 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.
Drug: Placebo
One matching placebo tablet orally administered at baseline phase.
Drug: Canagliflozin 50 mg
One 50-mg tablet of canagliflozin orally administered daily for 14 days.
Drug: Canagliflozin 300 mg
One 300-mg tablet of canagliflozin orally administered daily for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Days 14 to 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Days -1 to 1, and from Days 14 to 15
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.
From Days -1 to 1, and from Days 14 to 15
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.
From Days -1 to 1, and from Days 14 to 15
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.
Day 14
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Approximately 50 days
Approximately 50 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR103045
  • 28431754DIA1055 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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