Diabetes Mellitus, Type 2Phase 1NCT02000700
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus
A Phase 1 study testing Canagliflozin 100 mg, Canagliflozin 50 mg and Canagliflozin 300 mg in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 17 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Canagliflozin 100 mg, Canagliflozin 50 mg and Canagliflozin 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Mar 2014to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States13 sites
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Kansas City, Missouri
Study site
Lenexa, Kansas
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
New Haven, Connecticut
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
Toledo, Ohio
Brazil4 sites
Study site
Campinas
Study site
Curitiba
Study site
Ribeirão Preto
Study site
São Paulo
About this study
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
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.
Read the 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
- Being tested
- Canagliflozin 100 mg, Canagliflozin 50 mg, Canagliflozin 300 mg, Placebo
- Keywords
- Diabetes Mellitus, Type 2, Canagliflozin, JNJ-28431754, Pharmacokinetics, Pharmacodynamics, Children, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 100 mgDrug
One 100-mg tablet of canagliflozin orally administered daily for 14 days.
Canagliflozin 50 mgDrug
One 50-mg tablet of canagliflozin orally administered daily for 14 days.
Canagliflozin 300 mgDrug
One 300-mg tablet of canagliflozin orally administered daily for 14 days.
PlaceboDrug
One matching placebo tablet orally administered at baseline phase.
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin (Dose Group 1) | Experimental | Participants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days. Receives: Drug: Canagliflozin 100 mg; Drug: Placebo |
| Canagliflozin (Dose Group 2) | Experimental | 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. Receives: Drug: Canagliflozin 50 mg; Drug: Canagliflozin 300 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Measured: From Days 14 to 17
Secondary outcomes (5)
Plasma glucose concentration following multiple oral doses of canagliflozin
Plasma glucose is equal to the amount of glucose in the plasma at the defined time points.
Measured: From Days -1 to 1, and from Days 14 to 15
Urine glucose excretion following multiple oral doses of canagliflozin
Urine glucose excretion is equal to the amount of glucose excreted into the urine over defined time intervals.
Measured: From Days -1 to 1, and from Days 14 to 15
Renal threshold for glucose excretion following multiple oral doses of canagliflozin
Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.
Measured: From Days -1 to 1, and from Days 14 to 15
Acceptability of the canagliflozin tablet
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.
Measured: Day 14
Number of participants with adverse events as a measure of safety and tolerability
Measured: Approximately 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000700
- Sponsor's protocol ID
- CR103045
- Other IDs
- 28431754DIA1055
- Status last verified
- Feb 2017
- First submitted
- 27 Nov 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02000700
- Acronym / sponsor ID
- CR103045
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Canagliflozin, JNJ-28431754, Pharmacokinetics, Pharmacodynamics, Children, Adolescents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canagliflozin (Dose Group 1) | Experimental | Drug: Canagliflozin 100 mg, Drug: PlaceboParticipants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days. |
| Canagliflozin (Dose Group 2) | Experimental | Drug: Canagliflozin 50 mg, Drug: Canagliflozin 300 mg, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canagliflozin 100 mgOne 100-mg tablet of canagliflozin orally administered daily for 14 days. | Drug | Canagliflozin (Dose Group 1) |
| Canagliflozin 50 mgOne 50-mg tablet of canagliflozin orally administered daily for 14 days. | Drug | Canagliflozin (Dose Group 2) |
| Canagliflozin 300 mgOne 300-mg tablet of canagliflozin orally administered daily for 14 days. | Drug | Canagliflozin (Dose Group 2) |
| PlaceboOne matching placebo tablet orally administered at baseline phase. | Drug | Canagliflozin (Dose Group 1), Canagliflozin (Dose Group 2) |
Primary outcome
Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin
Time frame: From Days 14 to 17
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
5 secondary outcomes
Plasma glucose concentration following multiple oral doses of canagliflozin
Time frame: From Days -1 to 1, and from Days 14 to 15
Urine glucose excretion following multiple oral doses of canagliflozin
Time frame: From Days -1 to 1, and from Days 14 to 15
Renal threshold for glucose excretion following multiple oral doses of canagliflozin
Time frame: From Days -1 to 1, and from Days 14 to 15
Acceptability of the canagliflozin tablet
Time frame: Day 14
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Approximately 50 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- 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 MetforminLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Canagliflozin 100 mg, Canagliflozin 50 mg and Canagliflozin 300 mg in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin (time frame: From Days 14 to 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.