Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes
Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes
High blood glucose levels in hospitalized patients with diabetes are associated with
 increased risk of medical complications. Improved glucose control with insulin injections may
 improve clinical outcome and prevent some of the hospital complications. It is not known;
 however, what is the best insulin regimen in hospitalized patients. Recently, the use of
 basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart,
 glulisine) has been shown to facilitate outpatient glycemic control with lower rate of
 hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will
 determine the efficacy and safety of the combination of detemir and aspart insulin in the
 inpatient management of subjects with diabetes. We hypothesize that in patients with type 2
 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus
 insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic
 events than treatment with twice a day NPH plus regular insulin before meals. 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.

 This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta
 and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will
 serve as principal investigator. A total of 65 patients will be recruited at Grady and 65
 patients at the Rush University Medical Center, Chicago, IL.
Inclusion Criteria:

 1. Males or females between the ages of 18 and 70 years admitted to a general medical
 service.

 2. A known history of type 2 diabetes mellitus > 3 months, receiving any combination of
 oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin
 therapy.

 3. 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:

 1. Subjects with increased blood glucose concentration, but without a known history of
 diabetes.

 2. Subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis
 and hyperosmolar hyperglycemic state, or ketonuria [63].

 3. 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.

 4. Patients with clinically relevant hepatic disease (ALT 2.5x > upper limit of normal),
 or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dL for males, or ≥
 1.8 mg/dL for females.

 5. History of drug or alcohol abuse within the last 2 years.

 6. Mental condition rendering the subject unable to understand the nature, scope, and
 possible consequences of the study.

 7. Patients with recognized or suspected endocrine disorders associated with increased
 insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism.

 8. Female subjects are pregnant or breast feeding at time of enrollment into the study.