Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): sliding scale regular insulin (SSRI); Basal Bolus; Basal Plus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): four-time daily in patients with T2DM admitted to general medicine and surgery wards.; glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed); glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Other intervention name(s): Novolin R; Lantus (insulin glargine); Apidra (insulin glulisine); Lantus (insulin glargine); Apidra (insulin glulisine)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Inpatient Hyperglycemia