Status:
WITHDRAWN
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
Lead Sponsor:
Emory University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00663624
Last Update
November 21 2013
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