Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
The study is a prospective randomized study comparing safety and effectiveness of a
 basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen
 with glargine once daily and supplemental doses of glulisine, and sliding scale regular
 insulin (SSI) on correction of insulin regimen for the hospital management of medical and
 surgical patients with type 2 diabetes.
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.