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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000700
• Other study ID #: CR103045
• Secondary ID: 28431754DIA1055
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2013
• Last updated: March 1, 2017
• Start date: March 2014
• Est. completion date: April 2016

Study information

• Verified date: February 2017
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Canagliflozin 100 mg
One 100-mg tablet of canagliflozin orally administered daily for 14 days.
• Canagliflozin 50 mg
One 50-mg tablet of canagliflozin orally administered daily for 14 days.
• Canagliflozin 300 mg
One 300-mg tablet of canagliflozin orally administered daily for 14 days.
• Placebo
One matching placebo tablet orally administered at baseline phase.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin	Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.	From Days 14 to 17
Secondary	Plasma glucose concentration following multiple oral doses of canagliflozin	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
Secondary	Urine glucose excretion following multiple oral doses of canagliflozin	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
Secondary	Renal threshold for glucose excretion following multiple oral doses of canagliflozin	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
Secondary	Acceptability of the canagliflozin tablet	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
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Approximately 50 days

External Links

•   Open-Label, Multicenter, Multiple Oral Dose Study to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents =10 to <18 years' age with Type 2 Diabetes Mellitus and Currently on a Stable Dose of Metformin