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

NCT02000700 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Canagliflozin 100 mg

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

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.

DRUG

Placebo

One matching placebo tablet orally administered at baseline phase.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000700 on ClinicalTrials.gov