Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)

High blood glucose levels in medical and surgery patients with diabetes are associated with
increased risk of in-hospital complications and death. Improved glucose control with insulin
injections may improve clinical outcome and prevent some of the hospital complications.
Numerous studies have shown that high blood glucose increases the risk of wound infection,
kidney failure and death. It is not known; however, what is the best insulin regimen in
patients who will undergo surgery. The use of repeated injections of regular insulin is
commonly used for glucose control in hospitalized patients with diabetes. Recently, the
combination of Lantus® and Apidra® insulins has been shown to improve glucose control with
lower rate of hypoglycemia (low blood sugar). The investigators' recent preliminary data also
indicate that a single daily dose of glargine plus corrective doses of glulisine before meals
if needed (Basal Plus) is effective in the management of medical and surgical patients with
type 2 diabetes mellitus (T2DM). The average daily blood glucose (BG) levels in patients
treated with Basal Plus is equivalent to levels in patients treated with Basal Bolus with
glargine once daily plus glulisine before meals (basal bolus regimen). The mean daily BG
levels in patients treated with basal plus are lower than those reported in patients treated
with sliding scale regular insulin (SSRI). Accordingly, the present study aims to determine
which insulin treatment is best for glucose control in hospitalized patients with diabetes
admitted to general medicine wards. Glargine, glulisine, and regular insulins are approved
for use in the treatment of patients with diabetes by the FDA. A total of 375 subjects with
type 2 diabetes will be recruited in this study. The sites for this study are Grady Memorial
Hospital, Emory University Hospital, the Atlanta VA Medical Center, Scott & White Memorial
Hospital and Clinic, and Medical University of South Carolina.

Inclusion Criteria:

- Males or females between the ages of 18 and 75 years admitted to a general medicine or
surgical services.

- A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone,
oral monotherapy, or with any combination of oral antidiabetic agents (sulfonylureas,
meglitinides, metformin, thiazolidinediones, dipeptidyl peptidase (DPP) IV
inhibitors).

- Patients admitted for non-cardiac elective or emergency surgery or trauma.

- Subjects must have an admission BG > 140 mg and < 400 mg/dL without laboratory
evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalent /L, potential
hydrogen (pH) < 7.30, or positive serum or urinary ketones).

Exclusion Criteria:

- Subjects with increased blood glucose concentration, but without a known history of
diabetes (stress hyperglycemia).

- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state,
or ketonuria [32].

- Patients with acute critical or surgical illness admitted to the ICU or expected to
require admission to the ICU.

- Patients admitted for coronary artery bypass graft (CABG) or patients receiving
continuous insulin infusion.

- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and
portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥
3.0 mg/dl).

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

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

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

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