A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents with Type 2 Diabetes Mellitus.
- Conditions
- Patients with type 2 diabetes mellitus (T2DM) on a stable dose of Metformin (receiving standard of care)MedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-005455-32-Outside-EU/EEA
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 16
- 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the pharmacokinetics of canagliflozin after multiple oral doses of canagliflozin in children and adolescent subjects with T2DM who are ?10 to <18 years of age and are currently taking a stable dose of metformin.;Secondary Objective: The secondary objectives are to:<br>• evaluate the pharmacodynamic effects of canagliflozin on plasma glucose levels, urinary glucose excretion, and the renal threshold for glucose after multiple oral doses and <br>•assess the acceptability of the canagliflozin tablets.<br>Safety and tolerability will also be assessed. <br>;Primary end point(s): Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin;Timepoint(s) of evaluation of this end point: From Days 14 to 17
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1/ Plasma glucose concentration following multiple oral doses of canagliflozin<br>2/ Urine glucose excretion following multiple oral doses of canagliflozin<br>3/ Renal threshold for glucose excretion following multiple oral doses of Canagliflozin<br>4/ Acceptability of the canagliflozin tablet<br>5/ Number of volunteers with adverse events as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: 1/ From Days -1 to 1, and from Days 14 to 15 <br>2/ From Days -1 to 1, and from Days 14 to 15 <br>3/ From Days -1 to 1, and from Days 14 to 15 <br>4/ Day 14<br>5/ Approximately 50 days