Clinical Trial Results:
Comparison of ambulatory glucose profile prior to and during pancreatic enzyme replacement therapy in patients with diabetes and pancreatic exocrine insufficiency: a single-arm phase IV trial
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Summary
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EudraCT number |
2017-001227-45 |
Trial protocol |
GB |
Global end of trial date |
31 May 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jun 2022
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First version publication date |
02 Jun 2022
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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 |
PHT/2017/20
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Additional study identifiers
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ISRCTN number |
ISRCTN14889127 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Portsmouth Hospitals NHS Trust
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Sponsor organisation address |
Queen Alexandra Hospital, Portsmouth, United Kingdom, PO6 3LY
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Public contact |
Linda Harndahl , Portsmouth Hospitals NHS Trust, 0044 02392286236, research.office@porthosp.nhs.uk
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Scientific contact |
Michael Cummings , Portsmouth Hospitals NHS Trust, 0044 02392286000, michael.cummings@porthosp.nhs.uk
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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 |
31 May 2019
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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 |
31 May 2019
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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 compare glucose variability in patients with diabetes and pancreatic exocrine insufficiency before starting pancreatic enzyme replacement therapy and 6 weeks after starting pancreatic enzyme replacement therapy.
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Protection of trial subjects |
The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation (ICH) and Good Clinical Practice guidelines. All regulatory, safety and other requirements for patient safety were maintained throughout the study.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
01 Jun 2017
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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 |
United Kingdom: 19
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Worldwide total number of subjects |
19
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EEA total number of subjects |
19
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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) |
14
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
19 participants were recruited from study opening (July 2017) until study closure in May 2019. All recruited participants completed the study; no participants withdrew. | |||||||||
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Pre-assignment
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Screening details |
Potential participants were screened against eligibility criteria prior to enrolment in the study. There was no screening test or other procedure carried out. Only those meeting all eligibility criteria were approached, consented and recruited and proceeded to undertake study-related activities. | |||||||||
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Period 1
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Period 1 title |
study period (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 |
No
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Arm title
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Pre-PERT | |||||||||
Arm description |
To compare glucose variability (represented by mean interquartile range (IQR) over 2 weeks) in patients with diabetes and PEI prior to starting PERT | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Creon
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
1–2 capsules, dose to be taken with each meal either taken whole or contents mixed with acidic fluid or soft food (then swallowed immediately without chewing)
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Arm title
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6 weeks after starting PERT | |||||||||
Arm description |
To compare glucose variability (represented by mean interquartile range (IQR) over 2 weeks) in patients with diabetes and PEI 6 weeks after starting PERT | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Creon
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
1–2 capsules, dose to be taken with each meal either taken whole or contents mixed with acidic fluid or soft food (then swallowed immediately without chewing)
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Baseline characteristics reporting groups
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Reporting group title |
study period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Within participant before and after treatment with PERT
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
For the purposes of this study, a decrease in mean 24-hour IQR of 1mmol/l is considered to be clinically significant
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End points reporting groups
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Reporting group title |
Pre-PERT
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Reporting group description |
To compare glucose variability (represented by mean interquartile range (IQR) over 2 weeks) in patients with diabetes and PEI prior to starting PERT | ||
Reporting group title |
6 weeks after starting PERT
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Reporting group description |
To compare glucose variability (represented by mean interquartile range (IQR) over 2 weeks) in patients with diabetes and PEI 6 weeks after starting PERT | ||
Subject analysis set title |
Within participant before and after treatment with PERT
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
For the purposes of this study, a decrease in mean 24-hour IQR of 1mmol/l is considered to be clinically significant
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End point title |
Mean glucose interquartile range | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Collected over 14 days using the Freestyle Libre Pro glucose monitoring system prior to and 6 weeks after starting PERT therapy.
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Statistical analysis title |
Comparisons before and after PERT using T-test | ||||||||||||||||
Statistical analysis description |
Simple descriptive statistical analysis will be undertaken to describe the parameters and groups, and will depend on whether the data is normally distributed or not. Within patient comparisons will either be undertaken using Paired t-test or Wilcoxon signed rank test. Across group comparison will be undertaken using either the Two-sample t-test or Mann-Whitney U test.
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Comparison groups |
Pre-PERT v 6 weeks after starting PERT v Within participant before and after treatment with PERT
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Number of subjects included in analysis |
57
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
< 0.05 [1] | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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| Notes [1] - p<0.05 was taken to be significant at the 95% confidence level |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were continuously monitored over a 10 week period as per the participant's involvement in the study.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
Non-serious adverse events
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Reporting group description |
A related AE is defined as an AE which is considered, by the Chief Investigator (CI), Principal Investigator (PI) or the Sponsor, to have a reasonable causal relationship with the subject’s participation in the study. This includes any AE that would not ordinarily have occurred but for that subject’s participation in the research protocol. The expression ‘reasonable causal relationship’ means to convey, in general, that there is evidence or argument to suggest a causal relationship, namely that the event is ‘possibly’, ‘probably’ or ‘definitely’ caused by the research protocol. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? 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. | |||
| None reported | |||
