Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394407
• Other study ID #: 419-2005
• Secondary ID: 419-2005
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2006
• Last updated: November 20, 2013
• Start date: September 2005
• Est. completion date: June 2006

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Drug:
• sliding scale regular insulin
SSRI acqhs
• glargine basal insulin and glulisine prandial insulin
glargine insulin once a day and glulisine insulin three times a day as long as patient eating

Locations

Country	Name	City	State
United States	University of Miami School of Medicine	Coral Gables	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Sanofi, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose control	Differences in BG control will be assessed between the 2 arms acqhs and as needed for those patients hospitalized on the non-medical floors	During hospitalization	No
Secondary	frequency of hypoglycemia	assess differences in the frequency of hypoglycemia between the 2 study arms	during the hospitalization	Yes
Secondary	frequency of severe hyperglycemia (BG > 400 mg/dl),	evaluate differences in severe hyperglycemia between the 2 study arms	during the hospitalization	Yes
Secondary	length of hospital stay	differences in LOS between study arms	during hospitalization	No
Secondary	inflammatory markers	C-reactive protein, interleukin-6, and tumor necrosis factor	during hospitalization	No