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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:
ClinicalTrials.gov Identifier:
NCT00135070
First Posted: August 25, 2005
Last Update Posted: May 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Royal Bournemouth Hospital
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00135070     History of Changes
Other Study ID Numbers: H.P.I.1
First Submitted: August 23, 2005
First Posted: August 25, 2005
Last Update Posted: May 1, 2007
Last Verified: April 2007

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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs