Sub-Cutaneous Insulin in Hyperglycaemic Emergencies

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00467246
• Other study ID #: HIPI2
• Status: Withdrawn
• Phase: N/A
• First received: April 27, 2007
• Last updated: April 27, 2007

Study information

• Verified date: April 2007
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Emergencies

Intervention

Drug:
• Levemir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to normoglycaemia
Primary	Reduction of recurrence of ketoacidosis and hyperglycaemia.
Secondary	To investigate time to treatment in patients presenting with a hyperglycaemic emergency