Sub-Cutaneous Insulin in Hyperglycaemic Emergencies - Full Text View

Sponsor:	The Royal Bournemouth Hospital
Information provided by:	The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:	NCT00467246

Purpose

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.

Condition	Intervention
Diabetes Mellitus	Drug: Levemir

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:

Time to normoglycaemia
Reduction of recurrence of ketoacidosis and hyperglycaemia.

Secondary Outcome Measures:

To investigate time to treatment in patients presenting with a hyperglycaemic emergency

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients presenting with a diabetic emergency aged 18 and above.

Exclusion Criteria:

Patients who do not speak English and need a translator.
Patients under the age of 18 years.
Patients who are unable to give their consent and who do not have a relative present wiling to give assent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467246

Sponsors and Collaborators

The Royal Bournemouth Hospital

Investigators

Principal Investigator:	David Kerr, MD	Royal Bournemouth Hospital
Study Director:	Martin Taylor, MD	Royal Bournemouth Hospital

More Information

No publications provided

Study ID Numbers:	HIPI2
Study First Received:	April 27, 2007
Last Updated:	April 27, 2007
ClinicalTrials.gov Identifier:	NCT00467246 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:

Diabetes emergencies

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Metabolic Diseases
Diabetes Mellitus

Endocrine System Diseases
Emergencies
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2009