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Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

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. Identifier: NCT00591227
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : May 5, 2011
Last Update Posted : May 5, 2011
Novo Nordisk A/S
Information provided by:
Rush University Medical Center

Brief Summary:
This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: insulins aspart and detemir Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
Study Start Date : May 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1-aspart detemir
these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
Drug: insulins aspart and detemir
insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
No Intervention: 2 usual care
these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.

Primary Outcome Measures :
  1. Length of Stay in the Hospital [ Time Frame: from hospital admission to hospital discharge ]
  2. Hospital Length of Stay [ Time Frame: days ]
    hospital length of stay in days

Secondary Outcome Measures :
  1. Average Blood Glucose During the Hospital Admission [ Time Frame: from admission to discharge ]
  2. Frequency of Hypoglycemia [ Time Frame: from hospital admission to discharge ]
  3. Efficacy of Blood Glucose Lowering During the Emergency Room Stay [ Time Frame: from emergency room admission to discharge ]
  4. Frequency of Hypoglycemia During Emergency Room Therapy With Insulin [ Time Frame: from emergency room admission to discharge ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18-80 years
  2. History of type 2 diabetes mellitus for at least 3 months
  3. Prior therapy with dietary management, oral agents, or insulin
  4. Non child-bearing potential or a negative urine pregnancy test
  5. Initial blood glucose in ER > 200 mg/dl

Exclusion Criteria:

  1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
  2. Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
  3. History of current drug or alcohol abuse.
  4. History of current mental illness
  5. Inability to give informed consent
  6. Female patients who are pregnant or are breast feeding
  7. Patients who have clinically significant liver disease with ALT/AST > 3 times the upper range of normal
  8. Patients currently treated with dialysis

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 identifier (NCT number): NCT00591227

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Novo Nordisk A/S
Principal Investigator: David Baldwin, MD Rush University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Baldwin MD Director of Section of Endocrinology, Rush University Medical Center Identifier: NCT00591227     History of Changes
Other Study ID Numbers: 07070902
First Posted: January 11, 2008    Key Record Dates
Results First Posted: May 5, 2011
Last Update Posted: May 5, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs