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

NCT ID: NCT00394407

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-06-30

Brief 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).

Detailed 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.

Conditions

Diabetes; Hyperglycemia

Keywords

inpatient; diabetes management; insulin therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sliding scale regular insulin

sliding scale insulin given acqhs

Group Type: ACTIVE_COMPARATOR

sliding scale regular insulin

Intervention Type: DRUG

SSRI acqhs

glargine insulin and glulisine insulin

glargine basal insulin once a day with prandial glulisine insulin tid

Group Type: ACTIVE_COMPARATOR

glargine basal insulin and glulisine prandial insulin

Intervention Type: DRUG

glargine insulin once a day and glulisine insulin three times a day as long as patient eating

Interventions

sliding scale regular insulin

SSRI acqhs

Intervention Type: DRUG

glargine basal insulin and glulisine prandial insulin

glargine insulin once a day and glulisine insulin three times a day as long as patient eating

Intervention Type: DRUG

Other Intervention Names

Novolin-R; Lantus inuslin, Apidra insulin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo E Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

University of Miami School of Medicine

Coral Gables, Florida, United States

Countries

United States

References

Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.

Reference Type: DERIVED

PMID: 17513708 (View on PubMed)

Other Identifiers

419-2005

Identifier Type: OTHER

Identifier Source: secondary_id

419-2005

Identifier Type: -

Identifier Source: org_study_id