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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Canagliflozin 50 mg; Drug: Placebo; Drug: Canagliflozin 100 mg; Drug: Canagliflozin 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02000700

CR103045

28431754DIA1055 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

Canagliflozin (Dose Group 1)

Experimental group

Description:

Participants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days.

Treatment:

Drug: Placebo

Drug: Canagliflozin 100 mg

Canagliflozin (Dose Group 2)

Experimental group

Description:

Participants will be enrolled into Dose Group 2 to receive either 50 mg (as 1 x 50-mg tablet) or 300 mg (as 1 x 300-mg tablet) of canagliflozin daily for 14 days.

Treatment:

Drug: Placebo

Drug: Canagliflozin 50 mg

Drug: Canagliflozin 300 mg