Clinical trial NCT02000700: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Canagliflozin
JNJ-28431754
Pharmacokinetics
Pharmacodynamics
Children
Adolescents
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-12-04
Enrollment: 17
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin
timeFrame: From Days 14 to 17
Secondary outcomes:
measure: Plasma glucose concentration following multiple oral doses of canagliflozin
timeFrame: From Days -1 to 1, and from Days 14 to 15
measure: Urine glucose excretion following multiple oral doses of canagliflozin
timeFrame: From Days -1 to 1, and from Days 14 to 15
measure: Renal threshold for glucose excretion following multiple oral doses of canagliflozin
timeFrame: From Days -1 to 1, and from Days 14 to 15
measure: Acceptability of the canagliflozin tablet
timeFrame: Day 14
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Approximately 50 days
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Lenexa
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Toledo
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: