Back to resultsHospital In-Patient Insulin Study
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Detemir
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- The Royal Bournemouth Hospital
Outcomes
Primary Outcome Measures
Glucose control
Secondary Outcome Measures
Length of stay
Full Information
NCT ID
NCT00135070
First Posted
August 23, 2005
Last Updated
April 27, 2007
Sponsor
The Royal Bournemouth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00135070
Brief Title
Hospital In-Patient Insulin Study
Official Title
A Randomised Study Comparing Continuous Intravenous Insulin Infusion With Subcutaneous Insulin Analogues in Hospitalised Patients With Type II Diabetes and Hyperglycaemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
No documentation with MHRA to support clinical trial of a medicinal product.
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Royal Bournemouth Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Detemir
Primary Outcome Measure Information:
Title
Glucose control
Secondary Outcome Measure Information:
Title
Length of stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kerr, Doctor
Organizational Affiliation
The Royal Bournemouth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Hospital In-Patient Insulin Study
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