Clinical Trial Results:
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
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Summary
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EudraCT number |
2013-005455-32 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
01 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Oct 2016
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First version publication date |
08 Oct 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
28431754DIA1055
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02000700 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Research and Development, LLC
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Sponsor organisation address |
920 Route 202, Raritan, United States, NJ 08869
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Public contact |
Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001030-PIP01-10 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Apr 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Apr 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study was to evaluate the pharmacokinetics of canagliflozin after multiple oral doses of canagliflozin in children and adolescent subjects with type 2 diabetes mellitus (T2DM) who were more than or equal to (>=) 10 to less than (<) 18 years of age and on stable dose of metformin.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety and tolerability evaluations were based upon physical examinations, vital signs, electrocardiogram (ECGs), clinical laboratory tests (hematology, serum chemistry, and urinalysis), Glycemic Control, and adverse events (AEs) /serious adverse events (SAEs) reported throughout the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Apr 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Brazil: 4
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Country: Number of subjects enrolled |
United States: 13
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Worldwide total number of subjects |
17
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
1
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Adolescents (12-17 years) |
16
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted from 06 April 2014 to 01 April 2016 in United States of America (USA) and Brazil within a total of 17 subjects enrolled in the trial. | |||||||||
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Pre-assignment
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Screening details |
A total of 17 subjects received the study treatment and completed the study. | |||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Canagliflozin 100 milligram | |||||||||
Arm description |
Subjects received 100 milligram (mg)(1 x 100 mg) tablet of canagliflozin administered orally once daily for 14 days. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Canagliflozin
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Investigational medicinal product code |
JNJ-28431754
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received 100 mg tablet (1 x 100 mg) of canagliflozin administered orally once daily for 14 days.
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Arm title
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Canagliflozin 300 milligram | |||||||||
Arm description |
Subjects received 300 mg (1 x 300 mg) tablet of canagliflozin administered orally once daily for 14 days. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Canagliflozin
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Investigational medicinal product code |
JNJ-28431754
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received 300 mg (1 x 300 mg) tablet of canagliflozin administered orally once daily for 14 days.
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Baseline characteristics reporting groups
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Reporting group title |
Canagliflozin 100 milligram
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Reporting group description |
Subjects received 100 milligram (mg)(1 x 100 mg) tablet of canagliflozin administered orally once daily for 14 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Canagliflozin 300 milligram
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Reporting group description |
Subjects received 300 mg (1 x 300 mg) tablet of canagliflozin administered orally once daily for 14 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Canagliflozin 100 milligram
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Reporting group description |
Subjects received 100 milligram (mg)(1 x 100 mg) tablet of canagliflozin administered orally once daily for 14 days. | ||
Reporting group title |
Canagliflozin 300 milligram
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Reporting group description |
Subjects received 300 mg (1 x 300 mg) tablet of canagliflozin administered orally once daily for 14 days. | ||
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End point title |
Maximum Observed Plasma Concentration (Cmax) of Canagliflozin [1] | ||||||||||||
End point description |
Cmax is defined as maximum observed plasma concentration of canagliflozin. Pharmacokinetic (PK) population included all evaluable subjects who received at least 1 dose of study medication and with serial PK blood samples.
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End point type |
Primary
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End point timeframe |
Up to 72 hours postdose on Day 14
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The descriptive statistics was calculated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Canagliflozin [2] | ||||||||||||
End point description |
The Tmax is defined as actual sampling time to reach maximum observed concentration of Canagliflozin. PK population included all evaluable subjects who received at least 1 dose of study medication
and with serial PK blood samples.
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End point type |
Primary
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End point timeframe |
Up to 72 hours postdose on Day 14
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The descriptive statistics was calculated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Area Under the Curve From Time Zero to End of Dosing Interval (AUC tau) of Canagliflozin [3] | ||||||||||||
End point description |
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize Canagliflozin absorption. PK population included all evaluable subjects who received at least 1 dose of study medication and with serial PK blood samples.
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End point type |
Primary
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End point timeframe |
Up to 72 hours postdose on Day 14
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The descriptive statistics was calculated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Plasma Decay Half-Life (t1/2) of Canagliflozin [4] | ||||||||||||
End point description |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half of canagliflozin. PK population included all evaluable subjects who received at least 1 dose of study medication and with serial PK blood samples.
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End point type |
Primary
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End point timeframe |
Up to 72 hours postdose on Day 14
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The descriptive statistics was calculated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Elimination Rate Constant (Lambda[z]) of Canagliflozin [5] | ||||||||||||
End point description |
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. PK population included all evaluable subjects who received at least 1 dose of study medication
and with serial PK blood samples.
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End point type |
Primary
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End point timeframe |
Predose and 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours postdose on Day 14
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The descriptive statistics was calculated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Oral Clearance at Steady-State (CLss/F) of Canagliflozin [6] | ||||||||||||
End point description |
The Oral Clearance at Steady-State (CLss/F) is the steady state oral clearance based on oral bioavailability. PK population included all evaluable subjects who received at least 1 dose of study medication and with serial PK blood samples.
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End point type |
Primary
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End point timeframe |
Up to 72 hours postdose on Day 14
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The descriptive statistics was calculated for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean Plasma Glucose And Fasting Plasma Glucose (FPG) Concentrations | ||||||||||||||||||||||||||||||
End point description |
FPG is defined as fasting plasma glucose. MPG0-4h is defined as mean concentration of plasma glucose during the 0- to 4-hour (h) interval, calculated as area under curve (AUC) over 0 to 4h divided by the 4-hour time interval. MPG0-24h is the mean concentration for plasma glucose during the 0- to 24-hour interval, calculated as AUC over 0 to 24h divided by the 24-hour time interval. Pharmacodynamic population set included all evaluable subjects who received at least 1 dose of study medication. Here 'n' is defined as number of subjects analysed for the endpoint at specific timepoint.
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End point type |
Secondary
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End point timeframe |
Day-1 (Baseline) and Day 14
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Mean Urinary Glucose Excretion (UGE) | ||||||||||||||||||||||||||||||
End point description |
Urinary glucose excretion (UGE) is calculated from the measured individual subject urine glucose and urine volume data. UGEt1-t2 is defined as urinary glucose excretion, equal to the amount of urine glucose excreted into the urine over the time intervals 0 to 12 hours and 12 to 24 hours, abbreviated as UGE0-12h and UGE12-24h, respectively, calculated for each interval by multiplying the urinary volume with the urinary glucose concentration. UGE0-24h is defined as cumulative daily urinary glucose excretion, equal to the amount of plasma glucose excreted into the urine over the entire urine collection interval, 0 to 24 hours, calculated as the sum of UGE0-12h and UGE12-24h. Pharmacodynamic population set included all evaluable subjects who received at least 1 dose of study medication.
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End point type |
Secondary
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End point timeframe |
Day-1 (Baseline) and Day 14
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Mean Renal Threshold for Glucose Excretion (RTG) | ||||||||||||||||||||||||||||||
End point description |
RTG is defined as renal threshold for glucose. RTG,t1-t2 is defined as renal threshold for glucose excretion, calculated over the 0-12 and 12-24h time intervals. 24-h mean RTG is defined as 24-h mean renal threshold for glucose excretion, calculated as the average of the values obtained over the 0-12h and 12-24h intervals. Pharmacodynamic population set included all evaluable subjects who received at least 1 dose of study medication. The numeric value '999' indicates that on Day -1 (prior to treatment), many subjects had virtually no UGE and therefore their RTG values could not be determined. Values on Day -1 are shown only for the 2 subjects who had assessable values on this day.
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End point type |
Secondary
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End point timeframe |
Days -1 (Baseline), and 14
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Canagliflozin Tablet Acceptability Assessment Scores: Medicine's Taste | |||||||||||||||||||||||||||
End point description |
The acceptability questionnaire scores involves the general assessments for taste, smell, swallowing the
medicine, mouth taste after tablet swallow, Overall about taking the study medication again. For
Acceptability Assessment Scores: Medicine's Taste, the subjects were asked to choose one among
following options: Tastes bad, Does not taste good, Taste is not good or bad, Tastes OK, Tastes good,
There is no taste.
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End point type |
Secondary
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End point timeframe |
Day 14
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Canagliflozin Tablet Acceptability Assessment Scores: Medicine's Smell | |||||||||||||||||||||||||||
End point description |
The acceptability questionnaire scores involves the general assessments for taste, smell, swallowing the
medicine, mouth taste after tablet swallow, Overall about taking the study medication again. For
Acceptability Assessment Scores: Medicine's Smell, the subjects were asked to choose one among
following options: Smells bad, Does not smell good, Smell is not good or bad, Smells OK, Smells good,
There is no smell.
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End point type |
Secondary
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End point timeframe |
Day 14
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Canagliflozin Tablet Acceptability Assessment Scores: Medicine's swallowing property | ||||||||||||||||||||||||
End point description |
The acceptability questionnaire scores involves the general assessments for taste, smell, swallowing the
medicine, mouth taste after tablet swallow and Overall about taking the study medication again. For
Acceptability Assessment Scores: Medicine's swallowing property, the subjects were asked to choose
one among following options: Very hard to swallow, A little hard to swallow, Not hard or easy to
swallow, Easy to swallow, Very easy to swallow.
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End point type |
Secondary
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End point timeframe |
Day 14
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Canagliflozin Tablet Acceptability Assessment Scores: Medicine's Taste After Swallowing Tablet | |||||||||||||||||||||||||||
End point description |
The acceptability questionnaire scores involves the general assessments for taste, smell, swallowing the
medicine, mouth taste after tablet swallow, Overall about taking the study medication again. For
Acceptability Assessment Scores: Medicine's taste after swallowing tablet, the subjects were asked to
choose one among following options: Tastes bad, Does not taste good, Taste is not good or bad, Tastes
OK, Tastes good, There is no taste.
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End point type |
Secondary
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End point timeframe |
Day 14
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Canagliflozin Tablet Acceptability Assessment Scores: Overall Feel About Taking The Medication Again | ||||||||||||||||||||||||
End point description |
The acceptability questionnaire scores involves the general assessments for taste, smell, swallowing the
medicine, mouth taste after tablet swallow and Overall about taking the study medication again. For
Acceptability Assessment Scores: overall feel about taking the medication again, the subjects were
asked to choose one among following options: Very unhappy, Not happy, OK, Fine , Happy.
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End point type |
Secondary
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End point timeframe |
Day 14
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Number of Subjects with Adverse Events | |||||||||
End point description |
An Adverse event (AE) is any untoward medical occurrence in a subject who received study drug without
regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or
deemed significant for any other reason: death; initial or prolonged inpatient hospitalization;
lifethreatening
experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Safety population included all randomized subjects who received at least 1 dose of the study drug.
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End point type |
Secondary
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End point timeframe |
Up to follow up phase (7 to 10 days) after day 17 or whole study duration
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to follow up phase (7 to 10 days) after day 17 or whole study duration
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Canagliflozin 100 milligram
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Reporting group description |
Subjects received 100 milligram (mg)(1 x 100-mg) tablet of canagliflozin adminstered orally daily for 14 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Canagliflozin 300 milligram
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Reporting group description |
Subjects received 300 mg (1 x 300-mg) tablet of canagliflozin administered orally daily for 14 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Oct 2013 |
The overall reason for the amendment was to address a comment from the United states food drug adminstration (US FDA) regarding the definition of renal function inclusion criteria and general clarifications of admission days and a few procedures. The restriction on male subjects for use of effective birth control method was removed as per this amendment. |
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30 Oct 2013 |
The overall reason for the amendment was to correct a typo defining the value of a non-acceptable estimated glomerular filtration rate (eGFR) and in exclusion criterion 8 Inclusion of contraceptive injection as an effective birth control method.
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09 Sep 2014 |
The overall reason for the amendment was to adjust and clarify the language of the Inclusion and Exclusion criteria, modify rules related to concomitant medications, and update the calculation of estimated glomerular filtration rate (eGFR; using Schwartz formula). |
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16 Sep 2014 |
The overall reason for the amendment was to ensure protocol consistency with health authority agreements for study design. Administration of antihyperglycemic agent (AHAs) for up to 7 days in the 8 to 2 weeks prior to the screening visit was not permitted as per this amendment. |
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21 Sep 2015 |
The overall reason for the amendment was to enhance study recruitment. The window period for screening safety assessments was widened from 7 days to 10 days. Updated information on diabetic ketoacidosis and handling of subjects surrounding this event was added. Subjects who were on metformin XR for at least 8 weeks prior to screening and switched to metformin immediate release (IR; at the same total daily dose)which was well tolerated for at least 2 weeks prior to Day ‑1 were allowed to participate in the study. The concurrent use of insulin with metformin to achieve sufficient glycemic control was allowed. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| No notable study limitations were identified by the Sponsor. | |||
