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

NCT ID: NCT02000700

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-04-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Canagliflozin (Dose Group 1)

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

Group Type: EXPERIMENTAL

Canagliflozin 100 mg

Intervention Type: DRUG

One 100-mg tablet of canagliflozin orally administered daily for 14 days.

Placebo

Intervention Type: DRUG

One matching placebo tablet orally administered at baseline phase.

Canagliflozin (Dose Group 2)

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.

Group Type: EXPERIMENTAL

Canagliflozin 50 mg

Intervention Type: DRUG

One 50-mg tablet of canagliflozin orally administered daily for 14 days.

Canagliflozin 300 mg

Intervention Type: DRUG

One 300-mg tablet of canagliflozin orally administered daily for 14 days.

Placebo

Intervention Type: DRUG

One matching placebo tablet orally administered at baseline phase.

Interventions

Canagliflozin 100 mg

One 100-mg tablet of canagliflozin orally administered daily for 14 days.

Intervention Type: DRUG

Canagliflozin 50 mg

One 50-mg tablet of canagliflozin orally administered daily for 14 days.

Intervention Type: DRUG

Canagliflozin 300 mg

One 300-mg tablet of canagliflozin orally administered daily for 14 days.

Intervention Type: DRUG

Placebo

One matching placebo tablet orally administered at baseline phase.

Intervention Type: DRUG

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Little Rock, Arkansas, United States

Los Angeles, California, United States

Aurora, Colorado, United States

New Haven, Connecticut, United States

Jacksonville, Florida, United States

Indianapolis, Indiana, United States

Lenexa, Kansas, United States

Baltimore, Maryland, United States

Kansas City, Missouri, United States

Toledo, Ohio, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Campinas, , Brazil

Curitiba, , Brazil

Ribeirão Preto, , Brazil

São Paulo, , Brazil

Countries

United States; Brazil

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=5713&filename=CR103045_CSR.pdf

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

Other Identifiers

28431754DIA1055

Identifier Type: OTHER

Identifier Source: secondary_id

CR103045

Identifier Type: -

Identifier Source: org_study_id