Type 1 Diabetes MellitusPhase 4NCT00472875
Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
A Phase 4 study testing Glibenclamide in people with Type 1 Diabetes Mellitus, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Glibenclamide
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2007to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
David Hopkins, MBBS FRCP
About 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.
Read the 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 blood sugar level by consuming sugar or starch (carbohydrate). The body also responds to low blood sugars by producing hormones such as adrenaline and cortisol, which help to restore blood sugar levels to normal. As the brain relies on sugar for fuel, it does not function properly if blood sugar levels drop too low, resulting in confusion and in extreme cases reduced conscious levels.
Repeated hypoglycaemia can blunt the protective symptoms and hormonal responses to hypoglycaemia limiting patients' ability to recognise and correct hypoglycaemia, putting them at high risk of even more hypoglycaemia (Heller and Cryer, 1991).
Sulphonylureas are tablets used to treat type 2 diabetes that work by stimulating the pancreas to make more insulin. They do this by closing pores called KATP channels which are found on the surface of many cells and control the rate of firing of cells. In the pancreas, closing them causes cells to fire and release insulin. However, in other tissues such as in the brain, these channels have a protective function and they open up during times of lack of fuel, such as lack of oxygen or sugar, preventing the cells from firing and putting them into a resting mode which reduces their energy requirement(Dunn-Meynell, Rawson and Levin 1998). However, if the brain cells responsible for generating symptoms are put into this resting mode, they may not produce symptoms, which may contribute to hypoglycaemia unawareness.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Glibenclamide
- Keywords
- hypoglycaemia, type 1 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlibenclamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia
Measured: 1 year
Secondary outcomes (1)
Improvement in counter regulatory hormone response to hypoglycaemia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Pratik Choudhary, MBBS MRCP, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472875
- Sponsor's protocol ID
- 07/Q0703/18
- Other IDs
- JDRF grant number 5-2007-478
- Status last verified
- May 2007
- First submitted
- 10 May 2007
- Last updated
- 14 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?
- ClinicalTrials.gov ID
- NCT00472875
- Acronym / sponsor ID
- 07/Q0703/18
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- hypoglycaemia, type 1 diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- May 2007
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 blood sugar level by consuming sugar or starch (carbohydrate). The body also responds to low blood sugars by producing hormones such as adrenaline and cortisol, which help to restore blood sugar levels to normal. As the brain relies on sugar for fuel, it does not function properly if blood sugar levels drop too low, resulting in confusion and in extreme cases reduced conscious levels.
Repeated hypoglycaemia can blunt the protective symptoms and hormonal responses to hypoglycaemia limiting patients' ability to recognise and correct hypoglycaemia, putting them at high risk of even more hypoglycaemia (Heller and Cryer, 1991).
Sulphonylureas are tablets used to treat type 2 diabetes that work by stimulating the pancreas to make more insulin. They do this by closing pores called KATP channels which are found on the surface of many cells and control the rate of firing of cells. In the pancreas, closing them causes cells to fire and release insulin. However, in other tissues such as in the brain, these channels have a protective function and they open up during times of lack of fuel, such as lack of oxygen or sugar, preventing the cells from firing and putting them into a resting mode which reduces their energy requirement(Dunn-Meynell, Rawson and Levin 1998). However, if the brain cells responsible for generating symptoms are put into this resting mode, they may not produce symptoms, which may contribute to hypoglycaemia unawareness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glibenclamide | Drug | – |
Primary outcome
Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia
Time frame: 1 year
1 secondary outcome
Improvement in counter regulatory hormone response to hypoglycaemia
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pratik Choudhary, MBBS MRCP principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glibenclamide in people with Type 1 Diabetes Mellitus, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pratik Choudhary, MBBS, MRCP (+44 203 299 9000 ext. 2311, pratik.choudhary@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose threshold for development of symptoms and cognitive impairment due to hypoglycaemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2007.