Clinical trial NCT00979628
Conditions: Type 2 Diabetes Hyperglycemia
Keywords: Type 2 Diabetes Inpatient Hyperglycemia
Sponsor: Guillermo Umpierrez, MD
Start date: 2010-01-01; Completion date: 2012-06-01
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: glargine subcutaneously once daily plus corrective doses of glulisine subcutaneously before meals and bedtime as needed arm 2: glargine subcutaneously once daily plus glulisine subcutaneously before meals (plus corrective doses of glulisine as needed) arm 3: sliding scale regular insulin subcutaneously four-times daily in patients with T2DM admitted to general medicine and surgery wards.
Interventions: intervention 1: sliding scale regular insulin (SSRI) intervention 2: Basal Bolus intervention 3: Basal Plus
Intervention descriptions: intervention 1: four-time daily in patients with T2DM admitted to general medicine and surgery wards. intervention 2: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed) intervention 3: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed

Protocol documents: