Do sulphponylureas preserve cortical function during hypoglycaemia in patients with type 1 diabetes and hypoglycaemia unawareness? - Do Sulphonylureas preserve cortical function during hypoglycaemia?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000497-23-GB

Enrollment

Registered

2007-03-09

Start date

2007-05-02

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Le

Interventions

Trade Name: Glibenclamide Product Name: Glibenclamide Product Code: 4543/0282 Pharmaceutical Form: Capsule, hard INN or Proposed INN: GL

Eligibility

Sex/Gender

All

Inclusion 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 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: 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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaulate the effect of K ATP channel blockade with glibenclamide on the symptomatic and counterregulatory hormonal responses to experimental hypoglycaemia. ;Secondary Objective: To assess the effect of K ATP channel blockade with glibenclamide on cognitive function during experimental hypoglycaemia. ; 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.	—

Measure

Time frame

Main Objective: To evaulate the effect of K ATP channel blockade with glibenclamide on the symptomatic and counterregulatory hormonal responses to experimental hypoglycaemia. ;Secondary Objective: To assess the effect of K ATP channel blockade with glibenclamide on cognitive function during experimental hypoglycaemia. ; 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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026