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NCT00135070 Clinical Trial

Hospital In-Patient Insulin Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Randomised Study Comparing Continuous Intravenous Insulin Infusion With Subcutaneous Insulin Analogues in Hospitalised Patients With Type II Diabetes and Hyperglycaemia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00135070
Other study ID # H.P.I.1
Secondary ID
Status Terminated
Phase Phase 4
First received August 23, 2005
Last updated April 27, 2007
Start date July 2005
Est. completion date June 2006

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

Hyperglycaemia has been shown to increase morbidity and mortality in patients with critical illness, myocardial infarction and stroke. This study aims to look at patients with hyperglycaemia and reduce their blood sugar levels using differing combinations of subcutaneous and intravenous insulin.

Description:

This is a randomised trial involving patients with type II diabetes who are brought into the hospital with a problem other than a diabetic emergency. Patients will be included, who have a blood sugar > than 17mmols. They will be randomised to one of two groups and either given intravenous or subcutaneous insulin. Outcome measures are length of stay, glucose control and comparison of the two regimens. Cost implications will also be analysed.

Recruitment information / eligibility
Status Terminated
Enrollment 41
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Type II diabetes

- Blood glucose > 17mmols

Exclusion Criteria:

- Type I diabetes

- Hyperosmolar non-ketotic coma (HONK)

- Diabetic ketoacidosis (DKA)

- Myocardial infarction (MI)

- Vomiting

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Detemir

Locations
Country Name City State
United Kingdom The Royal Bournemouth Hospital Bournemouth Dorset

Sponsors (1)
Lead Sponsor Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glucose control
Secondary Length of stay
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