Clinical Trial Results:
Pasireotide in the treatment of hypoglycemia following gastric bypass surgery
Summary
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EudraCT number |
2018-001067-23 |
Trial protocol |
DK |
Global end of trial date |
13 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
13 May 2020
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First version publication date |
13 May 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 |
PasHypo
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03514576 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Urd Lynge Kielgast
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Sponsor organisation address |
Lykkebækvej 1, Køge, Denmark, 4600
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Public contact |
Caroline Christfort Øhrstrøm, Zealand University Hospital, 45 60625505, cacg@regionsjaelland.dk
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Scientific contact |
Caroline Christfort Øhrstrøm, Zealand University Hospital, 45 60625505, cacg@regionsjaelland.dk
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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 |
01 Oct 2018
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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 |
13 Aug 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 investigate the effects of both 75 ug pasireotide (P75) and 150 ug pasireotide (P150) on the postprandial blood glucose response in RYGB operated patients with hypoglycemia.
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Protection of trial subjects |
Subjects were asked to rest in a hospital bed during the mixed meal test. The intravenous catheter was inserted by a trained physician in order to minimise injection related pain and discomfort.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2018
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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 |
Denmark: 5
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Worldwide total number of subjects |
5
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EEA total number of subjects |
5
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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) |
5
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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 |
Subjects were recruited based on prior participation in the clinical trial HypoGB2015 (EudraCT number 2015-001086-50) | |||||||||||||||
Pre-assignment
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Screening details |
Medical assessment. | |||||||||||||||
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 | |||||||||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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Baseline | |||||||||||||||
Arm description |
Participants underwent a mixed meal tolerance test without prior treatment. | |||||||||||||||
Arm type |
No intervention | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Pasireotide 75 | |||||||||||||||
Arm description |
Participants underwent a mixed meal tolerance test preceded by an injection of 75 ug pasireotide. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
pasireotide
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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 |
A 75 ug gram dose was administered as a subcutaneous injection 30 minutes prior to the mixed meal test.
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Arm title
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Pasireotide 150 | |||||||||||||||
Arm description |
Participants underwent a mixed meal tolerance test preceded by an injection of 150 ug pasireotide. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
pasireotide
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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 |
A 150 ug dose was administered as a subcutanous injection 30 minutes prior to the mixed meal test.
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Arm title
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Pasireotide 300 | |||||||||||||||
Arm description |
Participants underwent a mixed meal tolerance test preceded by an injection of 300 ug pasireotide. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
pasireotide
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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 |
A dose of 300 ug was administered as a subcutanous injection 30 minutes prior to the mixed meal test
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
Participants underwent a mixed meal tolerance test without prior treatment. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pasireotide 75
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Reporting group description |
Participants underwent a mixed meal tolerance test preceded by an injection of 75 ug pasireotide. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pasireotide 150
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Reporting group description |
Participants underwent a mixed meal tolerance test preceded by an injection of 150 ug pasireotide. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pasireotide 300
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Reporting group description |
Participants underwent a mixed meal tolerance test preceded by an injection of 300 ug pasireotide. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline
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Reporting group description |
Participants underwent a mixed meal tolerance test without prior treatment. | ||
Reporting group title |
Pasireotide 75
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Reporting group description |
Participants underwent a mixed meal tolerance test preceded by an injection of 75 ug pasireotide. | ||
Reporting group title |
Pasireotide 150
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Reporting group description |
Participants underwent a mixed meal tolerance test preceded by an injection of 150 ug pasireotide. | ||
Reporting group title |
Pasireotide 300
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Reporting group description |
Participants underwent a mixed meal tolerance test preceded by an injection of 300 ug pasireotide. |
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End point title |
Nadir glucose | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Nadir blood glucose concentration during a 3-hour mixed meal tolerance test
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Statistical analysis title |
Friedmann's test | ||||||||||||||||||||
Comparison groups |
Baseline v Pasireotide 75 v Pasireotide 150 v Pasireotide 300
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||||||
Method |
Friedmann's test | ||||||||||||||||||||
Confidence interval |
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End point title |
Peak glucose | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Peak blood glucose concentration during a 3-hour mixed meal tolerance test with and without prior pasireotide administration
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No statistical analyses for this end point |
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End point title |
Time in hypoglycemia | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time spent with blood glucose values <3.9 mmol/l during a 3-hour mixed meal tolerance test with and without prior pasireotide administration
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No statistical analyses for this end point |
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End point title |
Time in hyperglycemia | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time spent with blood glucose values >7.8 mmol/l during a 3-hour mixed meal tolerance test with and without prior pasireotide administration
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No statistical analyses for this end point |
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End point title |
iAUC glucose | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Incremental area under the curve for blood glucose during a 3-hour mixed meal tolerance test with and without prior pasireotide administration
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No statistical analyses for this end point |
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End point title |
iAUC insulin | ||||||||||||||||||||
End point description |
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End point type |
Other pre-specified
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End point timeframe |
Incremental area under the curve for plasma insulin during a 3-hour mixed meal tolerance test with and without prior pasireotide administration
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No statistical analyses for this end point |
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End point title |
iAUC C-peptide | ||||||||||||||||||||
End point description |
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End point type |
Other pre-specified
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End point timeframe |
Incremental area under the curve for plasma C-peptide during a 3-hour mixed meal tolerance test with and without prior pasireotide administration
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No statistical analyses for this end point |
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End point title |
iAUC GLP-1 | ||||||||||||||||||||
End point description |
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End point type |
Other pre-specified
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End point timeframe |
Incremental area under the curve for plasma GLP-1 (glucagon-like peptide 1) during a 3-hour mixed meal tolerance test with and without prior pasireotide administration
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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 |
During the 3 mixed meal tolerance test (3 hours) that were preceded by pasireotide administration.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
Pasireotide 75
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Reporting group description |
Participants received a 75 ug pasireotide injection 30 minutes prior to a mixed meal tolerance test. | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pasireotide 150
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Reporting group description |
Participants received a 150 ug pasireotide injection 30 minutes prior to a mixed meal tolerance test. | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pasireotide 300
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Reporting group description |
Participants received a 300 ug pasireotide injection 30 minutes prior to a mixed meal tolerance test. | ||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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. | |||
The mixed meal tolerance tests with the 75 ug and the 150 ug pasireotide dose were performed 2.2 years after the baseline and the 300 ug pasireotide mixed meal tolerance tests. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/31709494 |