Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To see if using medication called sulphonylureas can help improve symptoms which patients rely on to recognise low blood glucose levels ( hypoglycaemia) and also to see if they can reduce the slowing down in brain function which occurs at hypoglycaemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College Hospital NHS Trust
• Treatments: Glyburide

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)

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%) 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)