se of diazoxide in people with type 1 diabetes in acute hypoglycaemia

• Conditions: Hypoglycaemia; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-005011-93-GB
• Lead Sponsor: niversity of Dundee and NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-18
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Healthy adults (aged 18-55) with >5 years disease duration
2.On intensive insulin therapy (CSII or multiple daily injections)
3.HbA1C <8.0%
4.Ability to give written informed consent to participate in the study
5.BMI between 20-29

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.History of significant cardiac, hepatic, renal or neurological disease.
2.Significant head injury, epilepsy or hypoglycaemia-induced seizures.
3.Pregnancy.
4. Participants who are currently breast feeding
5.Participants on thiazide diuretics
6.Participants on other potassium channel openers (nicorandil, minoxidil)
7. Participants already on diazoxide or who have known documented allergy to diazoxide
8.Participants on medications with vasodilatory properties such as methyldopa, reserpine, theophyllines and nitrites.
9.Participants on hydantoins (fosphenytoin, phenytoin)
10.Significant anaemia Hb<11.0 and Hct<33%.
11.If they have donated blood in the last 30 days.
12.All those who have participated in a CTIMP in the last 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified