Clinical Trial Results:
Do sulphponylureas preserve cortical function during hypoglycaemia in patients with type 1 diabetes and hypoglycaemia unawareness?
Summary
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EudraCT number |
2007-000497-23 |
Trial protocol |
GB |
Global end of trial date |
22 Feb 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Apr 2019
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First version publication date |
26 Apr 2019
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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 |
07/Q0703/18
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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 Hospital
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Sponsor organisation address |
Denmark Hill, London, United Kingdom, SE59RS
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Public contact |
Dr Pratik Choudhary , King's College Hospital, +44 203 299 9000, pratik.choudhary@kcl.ac.uk
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Scientific contact |
Dr Pratik Choudhary , King's College Hospital, +44 0203 299 9000, pratik.choudhary@kcl.ac.uk
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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 |
Dr Pratik Choudhary , King's College London, +44 203 299 9000, pratik.choudhary@kcl.ac.uk
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Scientific contact |
Dr Pratik Choudhary , King's College London, +44 203 299 9000, pratik.choudhary@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 |
22 Feb 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Feb 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Feb 2014
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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 see if the use of sulphonylureas (glibenclamide) can help preserve symptoms or cognitive function during hypoglycaemia
Specifically to see if the use of sulphonylureas can -
1. Increase the symptoms in response to low blood glucose levels
2. Improve performance in brain function tests during low blood glucose levels
3. Increase the protective hormone responses to low blood glucose levels
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Protection of trial subjects |
At screening subjects will undergo physical examination and screening blood tests (liver
and renal function).
Any side effects reported will be documented according to trust policy and GCP
guidelines including start, duration, severity and outcome.
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Background therapy |
Patients continued on their usual background therapy | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Apr 2008
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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: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
15
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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 |
Participants were recruited from one clinical site between 2008 and 2014 | ||||||||||||||
Pre-assignment
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Screening details |
• Age 18-75 • Type 1 diabetes (WHO definition) of at least 5 years duration • History of impaired awareness of hypoglycaemia (capillary glucose readings <3.5mmol/l without symptoms on > 3 occasions in the past 3 months (those with intact symptoms will be unlikely to show an improvement and would not really benefit from taking any medication i | ||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||
Blinding implementation details |
Participants will
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Arms
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Arm title
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Full study | ||||||||||||||
Arm description |
Each subject will undergo 2 studies in random order, separated by not less than 2 weeks, having taken 7 days of either placebo or glibenclamide (a sulphonylurea). In each study, we will lower the blood sugar level gradually through a number of steps in a safe and controlled manner. At each step we will measure symptoms of low blood glucose and also ask the patient to perform a battery of computer based cognitive function tests designed to look at certain aspects of brain function. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Glibenclamide
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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 |
Each subject will undergo 2 studies in random order, separated by not less than 2 weeks, having taken 7 days of either placebo or 10mg glibenclamide
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Investigational medicinal product name |
Placebo
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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 |
Each subject will undergo 2 studies in random order, separated by not less than 2 weeks, having taken 7 days of either placebo or 10mg glibenclamide
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End points reporting groups
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Reporting group title |
Full study
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Reporting group description |
Each subject will undergo 2 studies in random order, separated by not less than 2 weeks, having taken 7 days of either placebo or glibenclamide (a sulphonylurea). In each study, we will lower the blood sugar level gradually through a number of steps in a safe and controlled manner. At each step we will measure symptoms of low blood glucose and also ask the patient to perform a battery of computer based cognitive function tests designed to look at certain aspects of brain function. |
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End point title |
Preservation of cortical function during hypoglycaemia [1] | ||||||
End point description |
To obtain preliminary data to investigate if the use of sulphonylureas can help preserve symptoms or cognitive function during hypoglycaemia
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End point type |
Primary
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End point timeframe |
During study day only.
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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: Please see attached document for results. |
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Attachments |
RESULTS |
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No statistical analyses for this end point |
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End point title |
Secondary endpoints | ||||||
End point description |
To obtain preliminary data to see if the use of sulphonylureas can -
1. Increase the symptoms in response to low blood sugar levels
2. Improve performance in brain function tests during hypoglycaemia
3. Increase the protective hormone responses to hypoglycaemia
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End point type |
Secondary
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End point timeframe |
During study days 1 & 2
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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 |
Duration of the trial.
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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: 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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27 Apr 2009 |
This amendment is to update the sponsorship status from single sponsorship by King’s College Hospital NHS Foundation Trust to Co-sponsorship by King’s College Hospital NHS Foundation Trust and King’s College London. The Pharmacovigilance section has now been updated to reflect current policy and the general format has been updated into a more GCP compliant format. A few additional sections have been added for clarification but not changing the conduct of the trial. It has also been stated that subject withdrawals shall be replaced so that the 10 patients required shall complete the trial. |
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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 |