Clinical Trial Results:
The effect of Exenatide on brown adipose tissue activity and energy expenditure in healthy young men
Summary
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EudraCT number |
2016-000238-23 |
Trial protocol |
NL |
Global end of trial date |
30 Jan 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Feb 2020
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First version publication date |
21 Feb 2020
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Other versions |
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 |
ExeBAT01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03002675 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Leiden University Medical Center
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Sponsor organisation address |
Albinusdreef 2, Leiden, Netherlands, 2333ZA
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Public contact |
Clinical trial information, Leiden University Medical Center, l.g.m.janssen@lumc.nl
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Scientific contact |
Clinical trial information, Leiden University Medical Center, l.g.m.janssen@lumc.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jan 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Jan 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jan 2018
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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 |
To evaluate the effect of Exenatide treatment on BAT activity and energy expenditure in healthy young subjects of South Asain and white Caucasian descent
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2016
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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 |
Netherlands: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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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 |
- | ||||||
Pre-assignment
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Screening details |
Inclusion Criteria - Dutch South Asian or white Caucasian male, 20-36 years - BMI ≥ 18 and ≤ 27 kg/m2 - Good general health | ||||||
Period 1
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Period 1 title |
baseline
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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exenatide | ||||||
Arm description |
- | ||||||
Arm type |
exenatide | ||||||
Investigational medicinal product name |
exenatide (Bydureon)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
2mg
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Period 2
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Period 2 title |
after exenatide
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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exenatide | ||||||
Arm description |
- | ||||||
Arm type |
exenatide | ||||||
Investigational medicinal product name |
exenatide (Bydureon)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
2mg
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Baseline characteristics reporting groups
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Reporting group title |
baseline
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
exenatide
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Reporting group description |
- | ||
Reporting group title |
exenatide
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Reporting group description |
- |
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End point title |
energy expenditure | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
after 12 weeks exenatide treatment
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Attachments |
Untitled (Filename: 20200204 eudract_exe_calorimetry.pdf) |
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Statistical analysis title |
exenatide_calorimetry | ||||||||||||
Comparison groups |
exenatide v exenatide
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Number of subjects included in analysis |
48
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-44
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-102 | ||||||||||||
upper limit |
15 | ||||||||||||
Notes [1] - Data were analysed by linear mixed models and are presented as mean±SEM. |
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End point title |
bat fdg uptake | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 weeks exenatide
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Attachments |
Untitled (Filename: 20200204 eudract_exe_bat_pet.pdf) |
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Statistical analysis title |
fdg uptake bat | |||||||||
Comparison groups |
exenatide v exenatide
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Number of subjects included in analysis |
48
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.05 | |||||||||
Method |
ANOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
21
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.84 | |||||||||
upper limit |
42 |
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Adverse events information
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Timeframe for reporting adverse events |
12 weeks exenatide
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
NA | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
total study population
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
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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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14 Oct 2016 |
adjust cooling protocol |
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26 Jan 2017 |
add questionnaires |
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24 Aug 2017 |
expand bmi and age inclusion criteria |
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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. | |||
None reported |