NCT00472875

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 down in brain function which occurs at hypoglycaemia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
Last Updated

May 14, 2007

Status Verified

May 1, 2007

First QC Date

May 10, 2007

Last Update Submit

May 10, 2007

Conditions

Type 1 Diabetes Mellitus

Keywords

hypoglycaemiatype 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia

    1 year

Secondary Outcomes (1)

  • Improvement in counter regulatory hormone response to hypoglycaemia

    1 year

Interventions

GlibenclamideDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Pratik Choudhary, MBBS MRCP

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pratik Choudhary, MBBS, MRCP

CONTACT

+44 203 299 9000pratik.choudhary@kcl.ac.uk

Stephanie A Amiel, MD, FRCP

CONTACT

+44 203 299 9000stephanie.amiel@kcl.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

May 1, 2007

Last Updated

May 14, 2007

Record last verified: 2007-05

Locations

GB(1)