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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00591227
First received: December 27, 2007
Last updated: April 8, 2011
Last verified: April 2011

December 27, 2007
April 8, 2011
May 2008
July 2009   (final data collection date for primary outcome measure)
  • Length of Stay in the Hospital [ Time Frame: from hospital admission to hospital discharge ] [ Designated as safety issue: No ]
  • Hospital Length of Stay [ Time Frame: days ] [ Designated as safety issue: No ]
    hospital length of stay in days
Same as current
Complete list of historical versions of study NCT00591227 on ClinicalTrials.gov Archive Site
  • Average Blood Glucose During the Hospital Admission [ Time Frame: from admission to discharge ] [ Designated as safety issue: No ]
  • Frequency of Hypoglycemia [ Time Frame: from hospital admission to discharge ] [ Designated as safety issue: Yes ]
  • Efficacy of Blood Glucose Lowering During the Emergency Room Stay [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: No ]
  • Frequency of Hypoglycemia During Emergency Room Therapy With Insulin [ Time Frame: from emergency room admission to discharge ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
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.
  • 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.
    Intervention: Drug: insulins aspart and detemir
  • 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.
Bernard JB, Munoz C, Harper J, Muriello M, Rico E, Baldwin D. Treatment of inpatient hyperglycemia beginning in the emergency department: a randomized trial using insulins aspart and detemir compared with usual care. J Hosp Med. 2011 May;6(5):279-84. doi: 10.1002/jhm.866.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00591227
07070902
No
David Baldwin MD Director of Section of Endocrinology, Rush University Medical Center
Rush University Medical Center
Novo Nordisk A/S
Principal Investigator: David Baldwin, MD Rush University Medical Center
Rush University Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP