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

Official Title: “Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus: a Randomized, Open Labeled, Non-inferiority Controlled Study”

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(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• To determine differences in glycemic control between Basal Plus(glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus glulisine before meals and SSRI
  • Time Frame: at the end of patient hospitalization and 2 weeks after discharge
    Safety Issue?: Yes

Secondary Measures

• To determine differences between treatments arms in # of hypoglycemic events, # of episodes of sever hyperglycemia, LOS, rate of post-op complications, and/or need for ICU admission
  • Time Frame: at the end of patient hospitalization and two weeks after discharge
    Safety Issue?: Yes

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, 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 mEq/L, 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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Emory University Other

Overall Clinical Trial Officials and Contacts

Guillermo Umpierrez, MD Principal Investigator Emory SOM  

Overall Contact: Guillermo Umpierrez, MD 4047781665 geumpie@emory.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00979628

Study ID Number: eIRB00020328

ClinicalTrials.gov Identifier: NCT00979628

Health Authority: United States: Institutional Review Board