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Hospital In-Patient Insulin Study

This study has been terminated.
(No documentation with MHRA to support clinical trial of a medicinal product.)
Sponsor:
Information provided by:
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT00135070
First received: August 23, 2005
Last updated: April 27, 2007
Last verified: April 2007
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Detemir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • Glucose control

Secondary Outcome Measures:
  • Length of stay

Enrollment: 41
Study Start Date: July 2005
Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135070

Locations
United Kingdom
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135070     History of Changes
Other Study ID Numbers: H.P.I.1
Study First Received: August 23, 2005
Last Updated: April 27, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013