Status:

COMPLETED

Use of Diazoxide in Acute Hypoglycaemia

Lead Sponsor:

University of Dundee

Collaborating Sponsors:

Juvenile Diabetes Research Foundation

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

18-55 years

Phase:

PHASE4

Brief Summary

The investigators know that intensive insulin therapy and tight glucose control is associated with reduction of diabetic complications. However, many patients on insulin don't achieve this because of ...

Detailed Description

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 fash...

Eligibility Criteria

Inclusion

  • 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
  • BMI between 20-29

Exclusion

  • History of significant cardiac, hepatic, renal or neurological disease.
  • Significant head injury, epilepsy or hypoglycaemia-induced seizures.
  • Pregnancy.
  • Breast feeding mothers.
  • Participants on thiazide diuretics
  • Participants on other potassium channel openers (nicorandil, minoxidil)
  • Participants on medications with vasodilatory properties such as methyldopa, reserpine, theophyllines and nitrites.
  • Participants on hydantoins (fosphenytoin, phenytoin)
  • Significant anaemia Hb\<11.0 and Hct\<33%.
  • If they have donated blood in the last 30 days.
  • All those who have participated in a CTIMP in the last 3 months
  • Participants who are already on diazoxide or who have a past history of allergy to diazoxide

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2013

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT01488136

Start Date

January 1 2012

End Date

March 1 2013

Last Update

October 14 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

NHS Tayside

Dundee, United Kingdom, DD1 9SY

Use of Diazoxide in Acute Hypoglycaemia | DecenTrialz