|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
30 June 2019 |
|
Main ID: |
EUCTR2007-000497-23-GB |
|
Date of registration:
|
09/03/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Do sulphponylureas preserve cortical function during hypoglycaemia in patients with type 1 diabetes and hypoglycaemia unawareness? - Do Sulphonylureas preserve cortical function during hypoglycaemia?
|
|
Scientific title:
|
Do sulphponylureas preserve cortical function during hypoglycaemia in patients with type 1 diabetes and hypoglycaemia unawareness? - Do Sulphonylureas preserve cortical function during hypoglycaemia? |
|
Date of first enrolment:
|
02/05/2007 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000497-23 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Inclusion criteria
• 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 intended just to increase symptoms)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exclusion criteria
• Pregnancy
• Severe systemic illness
• Active malignancy
• Severe complications of diabetes such as severe visual impairment, severe renal impairment, severe symptomatic autonomic neuropathy
• Untreated ischemic heart disease, recent stroke
• Lactose intolerance ( the placebo will contain lactose)
• Very poor diabetes control (HbA1c > 10%)
• Hypersensitivity to sulphonylureas or sulphonamides.
• Liver disease ( increase in ALT / AST > 3x ULN)
• Chronic Kidney Disease stage 4 or 5 ( eGFR < 30ml/min)
• Severe untreated thyroid or adrenal insufficiency ( must be treated and on
stable doses for at least 6 weeks)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
We are testing the hypothesis that closing the K ATP channels using sulphonylureas (glibenclamide) during experimental insulin induced hypoglycaemia can help retain cerebral function and help enhance symptoms of hypoglycaemia in those with type 1 diabetes and hypoglycaemia unawareness.
MedDRA version: 9.1
Level: LLT
Classification code 10020997
Term: Hypoglycaemia unawareness
MedDRA version: 9.1
Level: LLT
Classification code 10012608
Term: Diabetes mellitus insulin-dependent
|
|
Intervention(s)
|
Trade Name: Glibenclamide
Product Name: Glibenclamide
Product Code: 4543/0282
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: GLIBENCLAMIDE
CAS Number: 10238218
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
Primary end point(s): Glucose threshold for an increase in symptoms for hypoglycaemia
Total increase in symptoms in response to hypoglycaemia
Glucose threshold for an increase in counter-regulatory hormones inresponse to hypoglycaemia
total increase in counter-regulatory hormones in response to hypoglycaemia.
|
|
Secondary Objective: To assess the effect of K ATP channel blockade with glibenclamide on cognitive function during experimental hypoglycaemia.
|
|
Main Objective: To evaulate the effect of K ATP channel blockade with glibenclamide on the symptomatic and counterregulatory hormonal responses to experimental hypoglycaemia.
|
|
Secondary ID(s)
|
|
07/Q0703/18
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|