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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02000700
First received: November 27, 2013
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Canagliflozin 100 mg
Drug: Canagliflozin 50 mg
Drug: Canagliflozin 300 mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin [ Time Frame: From Days 14 to 17 ] [ Designated as safety issue: No ]
    Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.


Secondary Outcome Measures:
  • Plasma glucose concentration following multiple oral doses of canagliflozin [ Time Frame: From Days -1 to 1, and from Days 14 to 15 ] [ Designated as safety issue: No ]
    Plasma glucose is equal to the amount of glucose in the plasma at the defined time points.

  • Urine glucose excretion following multiple oral doses of canagliflozin [ Time Frame: From Days -1 to 1, and from Days 14 to 15 ] [ Designated as safety issue: No ]
    Urine glucose excretion is equal to the amount of glucose excreted into the urine over defined time intervals.

  • Renal threshold for glucose excretion following multiple oral doses of canagliflozin [ Time Frame: From Days -1 to 1, and from Days 14 to 15 ] [ Designated as safety issue: No ]
    Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.

  • Acceptability of the canagliflozin tablet [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Approximately 50 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canagliflozin (Dose Group 1)
Participants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days.
Drug: Canagliflozin 100 mg
One 100-mg tablet of canagliflozin orally administered daily for 14 days.
Drug: Placebo
One matching placebo tablet orally administered at baseline phase.
Experimental: 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.
Drug: Canagliflozin 50 mg
One 50-mg tablet of canagliflozin orally administered daily for 14 days.
Drug: Canagliflozin 300 mg
One 300-mg tablet of canagliflozin orally administered daily for 14 days.
Drug: Placebo
One matching placebo tablet orally administered at baseline phase.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000700

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 29 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02000700     History of Changes
Other Study ID Numbers: CR103045, 28431754DIA1055
Study First Received: November 27, 2013
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Diabetes Mellitus, Type 2
Canagliflozin
JNJ-28431754
Pharmacokinetics
Pharmacodynamics
Children
Adolescents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014