Hospital In-Patient Insulin Study

• Sponsor: The Royal Bournemouth Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00135070
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Detemir	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomised Study Comparing Continuous Intravenous Insulin Infusion With Subcutaneous Insulin Analogues in Hospitalised Patients With Type II Diabetes and Hyperglycaemia
• Study Start Date: Jul 1, 2005
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. Glucose control []

Secondary Outcome Measures

1. Length of stay []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Royal Bournemouth Hospital	Bournemouth	Dorset	United Kingdom	BH7 7DW

Sponsors and Collaborators

• The Royal Bournemouth Hospital

Investigators

• Principal Investigator: David Kerr, Doctor, The Royal Bournemouth Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00135070
• Other Study ID Numbers: H.P.I.1
• First Posted: Aug 25, 2005
• Last Update Posted: May 1, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: Diabetes Mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Detemir

Study Results

No Results Posted as of May 1, 2007