NCT00979628

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

Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Guillermo Umpierrez, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Hyperglycemia

Interventions

Type	Name	Description
DRUG	sliding scale regular insulin (SSRI)	four-time daily in patients with T2DM admitted to general medicine and surgery wards.
DRUG	Basal Bolus	glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
DRUG	Basal Plus	glargine once daily plus corrective doses of glulisine before meals and bedtime as needed

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2009-09-18
• Last updated: 2018-10-10
• Results posted: 2014-04-24

Locations

5 sites across 1 country: United States