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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02000700

Run by

Janssen Research & Development, LLC

People needed

17

Starts

2014-03-01

Expected to finish

2016-04-01

Last updated by the study team

2017-03-03

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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