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

Sponsors and Collaborators:	Emory University Sanofi-Aventis University of Miami
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00394407

Purpose

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.

Condition	Intervention	Phase
Diabetes Hyperglycemia	Drug: Glulisine and Glargine vs Regular Insulin	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes

Further study details as provided by Emory University:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	130
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females between the ages of 18 and 70 years admitted to a general medicine service.
A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
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:

Subjects with increased blood glucose concentration, but without a known history of diabetes.
Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [57].
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.
Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3.0.
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394407

Locations

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

Sponsors and Collaborators

Emory University

Sanofi-Aventis

University of Miami

Investigators

Principal Investigator:

Guillermo E Umpierrez, MD

Emory University

More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2007 May 18.

Study ID Numbers:	419-2005
Study First Received:	October 31, 2006
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00394407 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

inpatient
diabetes management
insulin therapy

Study placed in the following topic categories:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009