Comparative Trial Between Insulin Glargine Plus Apidra Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes

Condition(s) targeted: Diabetes; Hyperglycemia

Intervention: Glulisine and Glargine vs Regular Insulin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Guillermo E Umpierrez, MD, Principal Investigator, Affiliation: Emory University

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).

This study will compare how well regular insulin will compare to glargine (Lantus®) once daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type 2 diabetes and elevated blood glucose (sugar) levels. Lantus is a long-acting insulin which is given subcutaneously (under the skin) once daily. Apidra is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Regular insulin is a short-acting insulin in clinical use for more than 20 years that is also given subcutaneously several times per day. Lantus, Apidra and regular insulins are approved for use in the treatment of patients with diabetes by the FDA.

This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Jackson Memorial Hospital, Miami. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Jackson Memorial Hospital. This study is supported by Sanofi-Aventis Pharmaceuticals.

Official title: Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

The primary outcome of the study is to determine differences in glycemic

control as measured by mean daily blood glucose concentration between

insulin glargine once daily plus supplemental glulisine insulin versus

sliding scale regular insulin in hospitalized patients with type 2 diabetes.

Secondary outcome:

Secondary outcomes include differences between treatment groups in any of

the following measures: number of hypoglycemic events (BG < 60 mg/dl),

number of episodes of severe hyperglycemia (BG > 400 mg/dl),

length of hospital stay, and concentration of vascular inflammatory

markers [C-reactive protein, interleukin-6, and tumor necrosis factor -alpha.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

1. Males or females between the ages of 18 and 70 years admitted to a general medicine service.

2. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).

3. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).

Exclusion Criteria:

1. Subjects with increased blood glucose concentration, but without a known history of diabetes.

2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [57].

3. Patients with known HIV, acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), corticosteroid therapy, or to undergo surgery during the hospitalization course.

4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3. 0.

5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

6. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.

7. Female subjects are pregnant or breast feeding at time of enrollment into the study.

University of Miami School of Medicine, Coral Gables, Florida 33124, United States

Starting date: September 2005
Ending date: June 2006
Last updated: March 11, 2008