Clinical Trial Results:
The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency: a pilot study.
Summary
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EudraCT number |
2008-002336-15 |
Trial protocol |
GB |
Global end of trial date |
20 Sep 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
03 May 2019
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First version publication date |
03 May 2019
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Other versions |
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Summary report(s) |
FINAL STUDY REPORT |
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 |
578
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
King's College London
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Sponsor organisation address |
The Strand, London, United Kingdom, WC2R 2LS
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Public contact |
Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.ac.uk
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Scientific contact |
Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.ac.uk
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Sponsor organisation name |
King's College Hospital
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Sponsor organisation address |
Denmark Hill, London, United Kingdom, SE59RS
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Public contact |
Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.a.uk
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Scientific contact |
Prof Stephanie Amiel, King's College London, +44 0207848 5639, stephanie.amiel@kcl.ac.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 |
20 Sep 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Sep 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Sep 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
In people with type 1 diabetes and adrenal insufficiency, who are established on hydrocortisone as glucocorticoid replacement, frequency of nocturnal hypoglycaemia will be reduced by changing the glucocorticoid replacement from hydrocortisone to prednisolone
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Protection of trial subjects |
The trial included a familiarisation phase: 1 week The purpose of this phase is to familiarise study participants with the monitoring and recording processes required for the study and provide some baseline data. Participants to take their normal hydrocortisone regimen, as prescribed by their doctor. Insulin self adjustment and recording: o Participants to continue their normal insulin regimen. Dose adjustment according to their usual principles of flexible insulin therapy encouraged. o Participants to record their insulin doses taken in the DAFNE (Dose Adjustment For Normal Eating) Diary provided Self blood glucose monitoring: o Participants to continue usual monitoring of capillary blood glucose levels with a minimum of four readings per day. To record all capillary blood glucose readings taken in the DAFNE Diary provided o Participants to check capillary blood glucose readings at 3 am on one occasion during the week. Hypoglycaemia reporting: Participants to record details of all hypoglycaemic events on the Hypoglycaemia Record Sheet provided. To report all levels < 3mmol/l and provide details of the episode including time, glucose level, symptoms, recognition, treatment and possible precipitant. Adverse event / missed medication recording: participants to record unusual events (eg exercise/illness) and missed medication in the DAFNE Diary
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Background therapy |
The study lasts eleven weeks for each participant and consists of a one week familiarisation phase followed by the five week prednisolone phase and the five week hydrocortisone phase in random order. The study includes eight hospital visits. Extra visits may be required if the CGMS sensor stops working and needs to be replaced | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Dec 2012
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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: 3
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Worldwide total number of subjects |
3
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EEA total number of subjects |
3
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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) |
3
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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 |
Patients were recruited from the diabetes department of King's College Hospital NHS Foundation Trust. The first patient was recruited in December 2012. Only 2 further patients were recruited and the trial was terminated early in September 2017 due to lack of recruitment. | ||||||
Pre-assignment
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Screening details |
1. Age 2. Sex 3. Weight and height 4. Ethnic group 5. Date of diagnosis of diabetes 6. Current insulin regimen and start date 7. Date of participation in a DAFNE (Dose Adjustment For Normal Eating) course or similar 8. Presence of diabetes microvascular complications . | ||||||
Period 1
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Period 1 title |
Whole trial period (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
This was an open label study.
Participants will be randomised to either:
hydrocortisone phase followed by prednisolone phase,
or prednisolone phase followed by hydrocortisone phase.
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Arms
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Arm title
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Whole trial | ||||||
Arm description |
Participants will be randomised to either: hydrocortisone phase followed by prednisolone phase, prednisolone phase followed by hydrocortisone phase. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Prednisolone
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Investigational medicinal product code |
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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 |
15mg - prednisolone will be calculated equivalent to normal hydrocortisone regimen. Normal daily dose of hydrocortisone will be converted into the equivalent total dose of prednisolone using hydrocortisone 20mg = prednisolone 5mg.
Up to 15 mg per day in total
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Investigational medicinal product name |
Hydrocortisone
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Investigational medicinal product code |
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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 |
Maximum dose allowed 30 mg
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Baseline characteristics reporting groups
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Reporting group title |
Whole trial period
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Whole trial
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Reporting group description |
Participants will be randomised to either: hydrocortisone phase followed by prednisolone phase, prednisolone phase followed by hydrocortisone phase. |
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End point title |
Frequency of moderate nocturnal biochemical hypoglycaemia [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
From randomisation to last dose of IMP.
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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: No statistical analysis was possible for this trial as the trial terminated early due to lack of recruitment |
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Attachments |
Lack of data for analysis |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From consent to final study visit
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Whole trial
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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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: Hperglycaemia and hypoglycaemia were non-reportable AEs for this trial. No other AEs were reported for the 3 patients who completed treatment. |
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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 |