Completed

Use of Diazoxide in Acute Hypoglycaemia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Diazoxide

+ Placebo

Drug
Who is being recruted

Autoimmune Diseases+6

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 18 to 55 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 4
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorUniversity of Dundee
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

This will be conducted in a double blinded (neither subject nor the researcher will know the order of the IMP(drug/placebo). All subjects will receive both the active drug and placebo in a random fashion (crossover design). Once identified, patients will be given a participant information sheet. They will be contacted at a later date (minimum 24 hours) to determine if they are willing to participate in the trial. Subjects will then be consented, and attend a screening visit, where it will be ascertained whether they fit the inclusion/exclusion criteria. Further details of the study will also be given to them at this visit. They will then attend a few days before the first study, and will be shown how to use the continuous glucose monitor which will measure their glucose overnight, prior to the start of the study. The reason for this, is that if they have very low blood sugars the night before the study, this can influence the results of the study, and they will be given an alternative day to attend. Provided they have been free of any hypoglycaemic episodes, the night before, they can then proceed with the study. On the day of the study,we will place two intravenous cannulae. The cannulae in the hand vein will be placed in a warm chamber, in order to make it more more reflective of sampling at the blood brain barrier. The subject will either have the investigational medicinal product (diazoxide) or placebo. Blood pressure and heart rate will be monitored throughout the clamp study. After 2 hours, with the use of insulin and dextrose, the subject's blood sugar will be brought to near normal and kept there for 40 minutes. After this, the blood sugar will be dropped in stages, until a blood sugar of 2.5mmol/L is reached. The blood sugar will be monitored very closely, with 5 minute sampling taken through one of the cannulue in situ, to avoid repeated stabbing. Also at regular intervals, blood samples will be taken for measurement of hormones, including adrenaline. At each stage, subjects will be asked about symptoms they are experiencing and a series of verbal working memory tests will also be performed.

Official TitleUse of Diazoxide in Acute Hypoglycaemia
NCT01488136
Principal SponsorUniversity of Dundee
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesHypoglycemiaImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
Healthy adults (aged 18-55) with >5 years disease duration

On intensive insulin therapy (CSII or multiple daily injections)

HbA1C<8.0%

Ability to give written informed consent to participate in the study

Show More Criteria

12 exclusion criteria prevent from participating
History of significant cardiac, hepatic, renal or neurological disease.

Significant head injury, epilepsy or hypoglycaemia-induced seizures.

Pregnancy.

Breast feeding mothers.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Oral diazoxide 7 mg/kg

Group II

Placebo
Matched placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

NHS Tayside

Dundee, United KingdomOpen NHS Tayside in Google Maps
CompletedOne Study Center