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Type 1 Diabetes Mellitus | Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?

Type 1 Diabetes Mellitus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Type 1 Diabetes Mellitus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Glibenclamide

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: May 2007

Completed Date:

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia

Secondary Outcome: Improvement in counter regulatory hormone response to hypoglycaemia

Study sponsors, principal investigator, and references

Principal Investigator: Pratik Choudhary, MBBS MRCP

Lead Sponsor: King's College Hospital NHS Trust

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00472875

Discuss Hypoglycaemia