Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes
Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 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. The use of repeated
 injections of regular insulin (known as sliding scale regimen) is one of the most commonly
 used insulin regimen for glucose control in hospitalized patients with diabetes. Recently,
 the combination of basal and rapid acting insulins has been shown to improve glucose control
 with lower rate of hypoglycemia (low blood sugar).
This study will compare how well regular insulin will compare to glargine (Lantus®) once
 daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type 2
 diabetes and elevated blood glucose (sugar) levels. Lantus is a long-acting insulin which is
 given subcutaneously (under the skin) once daily. Apidra is a rapid-acting insulin which is
 given subcutaneously several times a day and frequently before meals. Regular insulin is a
 short-acting insulin in clinical use for more than 20 years that is also given subcutaneously
 several times per day. Lantus, Apidra and regular 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 Jackson Memorial Hospital, Miami. 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 Jackson Memorial Hospital. This study is supported by Sanofi-Aventis Pharmaceuticals.
Inclusion Criteria:

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

 2. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or
 any combination of oral antidiabetic agents (sulfonylureas, metformin,
 thiazolidinediones).

 3. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without
 laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or 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 diabetic ketoacidosis and hyperosmolar hyperglycemic state,
 or ketonuria [57].

 3. Patients with known HIV, acute critical or surgical illness and/or expected to require
 admission to a critical care unit (ICU, CCU), corticosteroid therapy, or to undergo
 surgery during the hospitalization course.

 4. Patients with clinically relevant hepatic disease or impaired renal function, as shown
 by a serum creatinine ≥3.0.

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

 6. Patients with recognized or suspected endocrine disorders associated with increased
 insulin resistance, acromegaly, or hyperthyroidism.

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