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Management of Hyperglycemia in the ER: 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 (NOVO ER)

This study has been withdrawn prior to enrollment.
(Lack of funding for the study at the Emory site)
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Dawn Smiley MD, Emory University
ClinicalTrials.gov Identifier:
NCT00663624
First received: April 18, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis and many patients with uncontrolled diabetes are admitted to the hospital after initial evaluation in the ED. Currently there are no guidelines in the US for the management of hyperglycemia in patients with diabetes during the duration of evaluation and treatment in the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. In this study, we hypothesize that a defined two-step approach to the management of high blood sugars with insulin injections initiated in the ED may decrease length of stay in the ED or hospital, improve clinical outcome and prevent some hospital complications. In the first phase, patients with diabetes admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive scheduled aspart or the usual care as dictated by the ED physicians. In the second phase, patients enrolled in the first phase that are subsequently admitted to the hospital will receive a combination of detemir and aspart insulin or usual care as dictated by the Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine.

This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120 patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo Nordisk.


Condition Intervention Phase
Diabetes
Drug: aspart insulin
Drug: Usual care as prescribed by the ED physicians.
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: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • to determine whether initiation of hyperglycemia management in the ED with scheduled aspart insulin for patients versus usual care with type 2 diabetes will result in a decrease in subsequent hospital length of stay. [ Time Frame: once all subjects have been recruited ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to determine diff. in the mean BG during the ED stay, the mean BG achieved during hospital, frequency of hypoglycemia during the ED and hospital visits among those treated with the scheduled protocol insulin regimen vs. usual hyperglycemia mgmt [ Time Frame: once all subjects have been recruited ] [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Experimental
Subcutaneous aspart insulin every 2 hours
Drug: aspart insulin
subcutaneous aspart insulin every 2 hours
Placebo Comparator: Active Comparator
Usual care as prescribed by the ED physicians
Drug: Usual care as prescribed by the ED physicians.
Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects meeting all of the following criteria will be considered for enrollment into the study:
  • Males or females between the ages of 18 and 80 years admitted to a general medical service.
  • A known history of type 2 diabetes mellitus > 3 months, receiving diet management, any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
  • Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive serum or urinary ketones).

Exclusion Criteria:

  • Subjects with increased blood glucose concentration, but without a known history of diabetes.
  • Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
  • Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course.
  • History of current drug or alcohol abuse.
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Inability to give informed consent
  • Female patients who are pregnant or are breast feeding
  • Patients who have clinically significant liver disease with ALT/AST > 3 X the upper range of normal
  • Patients with serum creatinine ≥3.5 mg/dL for males or ≥ 3.0 mg/dL for females or currently treated with dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663624

Sponsors and Collaborators
Emory University
Novo Nordisk A/S
Investigators
Principal Investigator: Dawn Smiley, MD Emory SOM
  More Information

No publications provided

Responsible Party: Dawn Smiley MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00663624     History of Changes
Other Study ID Numbers: IRB00008143, e8143
Study First Received: April 18, 2008
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014