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WithdrawnNCT00467246

Sub-Cutaneous Insulin in Hyperglycaemic Emergencies

The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
Sponsor
The Royal Bournemouth Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.

Detailed description

This is a randomised trial concerning patients presenting in A \& E with a diabetic emergency, either a Diabetic Ketoacidosis (DKA) or a Hyperosmolar Non-Ketotic Coma (HONC). Once informed consent has been given, each patient will receive standard intravenous treatment. They will also receive a daily sub-cutaneous bolus of either a long-acting insulin or a placebo. Blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood pH.

Conditions

Interventions

TypeNameDescription
DRUGLevemir

Timeline

First posted
2007-04-30
Last updated
2007-04-30

Source: ClinicalTrials.gov record NCT00467246. Inclusion in this directory is not an endorsement.

Sub-Cutaneous Insulin in Hyperglycaemic Emergencies (NCT00467246) · Clinical Trials Directory