Clinical Trial Results:
Pilot Study with Treatment of Short Bowel Syndrome Patients with end-jejunostomi with the Glucagon-Like Peptide-1 analogue, Liraglutide (Victoza®)
Summary
|
|
EudraCT number |
2013-005499-16 |
Trial protocol |
DK |
Global end of trial date |
20 Jun 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
26 Jun 2022
|
First version publication date |
26 Jun 2022
|
Other versions |
|
Summary report(s) |
manuscript supplementary material |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
2013-624
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Rigshospitalet
|
||
Sponsor organisation address |
Inge Lehmanns Vej 7, Copenhagen, Denmark, 2100
|
||
Public contact |
Palle Bekker Jeppesen, Department of Intestinal Failure and LIver Diseases, clinic 2101, +45 20481323, bekker@dadlnet.dk
|
||
Scientific contact |
Palle Bekker Jeppesen, Department of Intestinal Failure and LIver Diseases, clinic 2101, +45 20481323, bekker@dadlnet.dk
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
02 Oct 2014
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
20 Jun 2014
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
20 Jun 2014
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The objective of the trial is to assessthe therapeutic effect of the glucagon-like peptide-1 analogue, liraglutide (Victoza®) for SBS patients with an end-jejunostomi. The efficacy is assessed through the ability of liraglutide (Victoza®) to increase intestinal absorption, reduce diarrhea and the need for hyperphagia, and determine if liraglutide (Victoza®) can reduce the need for parenteral support.
|
||
Protection of trial subjects |
Several safety parameters were done during the trial period, including a physical examination, electrocardiography, vital signs, local tolerability and blood samples.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Feb 2014
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 8
|
||
Worldwide total number of subjects |
8
|
||
EEA total number of subjects |
8
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
3
|
||
From 65 to 84 years |
5
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
Dates of recruitment: from 3rd February 2014 to 17th March 2014. Recruitment was done through the out-patient clinic database at Department of Intestinal Failure and Liver Diseases, clinic 2101, Inge Lehmanns Vej 7, DK-2100 Copenhagen, Denmark | ||||||
Pre-assignment
|
|||||||
Screening details |
- | ||||||
Pre-assignment period milestones
|
|||||||
Number of subjects started |
8 | ||||||
Number of subjects completed |
8 | ||||||
Period 1
|
|||||||
Period 1 title |
Change after 8 weeks treatment
|
||||||
Is this the baseline period? |
No | ||||||
Allocation method |
Non-randomised - controlled
|
||||||
Blinding used |
Not blinded | ||||||
Blinding implementation details |
NA
|
||||||
Arms
|
|||||||
Arm title
|
8 weeks on liraglutide treatment | ||||||
Arm description |
All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values. | ||||||
Arm type |
Active comparator | ||||||
Investigational medicinal product name |
Liraglutide
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Injection
|
||||||
Routes of administration |
Subcutaneous use
|
||||||
Dosage and administration details |
Uptitration to 1.8 mg/day, subcutanous injections
|
||||||
|
|||||||
Period 2
|
|||||||
Period 2 title |
Baseline
|
||||||
Is this the baseline period? |
Yes [1] | ||||||
Allocation method |
Non-randomised - controlled
|
||||||
Blinding used |
Not blinded | ||||||
Arms
|
|||||||
Arm title
|
8 weeks on liraglutide treatment | ||||||
Arm description |
All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values. | ||||||
Arm type |
Active comparator | ||||||
Investigational medicinal product name |
Liraglutide
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Injection
|
||||||
Routes of administration |
Subcutaneous use
|
||||||
Dosage and administration details |
Uptitration to 1.8 mg/day, subcutanous injections
|
||||||
Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: Period 1 is the baseline period |
|||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Baseline
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
8 weeks on liraglutide treatment
|
||
Reporting group description |
All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values. | ||
Reporting group title |
8 weeks on liraglutide treatment
|
||
Reporting group description |
All endpoints and explorative assessments done at the first baseline balance study were repeated at this period "8 weeks on liraglutide treatment". All outcome data were compared with baseline values. |
|
|||||||||
End point title |
Change in wet weight ostomy output [1] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
After 8 weeks of treament
|
||||||||
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: system wont allow posting |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Change in wet weight dietary intake | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
After 8 weeks of treatment
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Urine volume | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from baseline after 8 weeks of treament
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Wet weight absorption | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from baseline after 8 weeks of treatment
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Instestinal energy absorption | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Change from baseline after 8 weeks of treatment
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
8 weeks treatment
|
||||||||||
Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
MedDRA | ||||||||||
Dictionary version |
1
|
||||||||||
Reporting groups
|
|||||||||||
Reporting group title |
After 8 weeks of treatment
|
||||||||||
Reporting group description |
- | ||||||||||
|
|||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
|
|||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: system wont allow posting |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |