Status:
UNKNOWN
Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Low blood glucose (hypoglycaemia) is the most common and important side effect of insulin treatment for diabetes. Most episodes are "mild" and lead to symptoms that alert the individual to raise their...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00472875
Start Date
May 1 2007
Last Update
May 14 2007
Active Locations (1)
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1
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS