Patients with type 2 diabetes mellitus (T2DM) on a stable dose of Metformin (receiving standard of care) MedDRA version: 16.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Canagliflozin
Product Code: JNJ-28431754
Pharmaceutical Form: Tablet
INN or Proposed INN: Canagliflozin
CAS Number: 842133-18-0
Current Sponsor code: JNJ-28431754
Other descriptive name:
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • evaluate the pharmacodynamic effects of canagliflozin on plasma glucose levels, urinary glucose excretion, and the renal threshold for glucose after multiple oral doses and •assess the acceptability of the canagliflozin tablets. Safety and tolerability will also be assessed. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Plasma glucose concentration following multiple oral doses of canagliflozin 2/ Urine glucose excretion following multiple oral doses of canagliflozin 3/ Renal threshold for glucose excretion following multiple oral doses of Canagliflozin 4/ Acceptability of the canagliflozin tablet 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 2/ From Days -1 to 1, and from Days 14 to 15 3/ From Days -1 to 1, and from Days 14 to 15 4/ Day 14 5/ Approximately 50 days | — |
Countries
Brazil, United States
Contacts
Public ContactClinical Registry Group
Janssen Research & Development
Outcome results
None listed