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

Primary Purpose

Diabetes, Hyperglycemia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

sliding scale regular insulin

glargine basal insulin and glulisine prandial insulin

About this trial

This is an interventional treatment trial for Diabetes focused on measuring inpatient, diabetes management, insulin therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Miami School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

sliding scale regular insulin

glargine insulin and glulisine insulin

Arm Description

sliding scale insulin given acqhs

glargine basal insulin once a day with prandial glulisine insulin tid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

frequency of hypoglycemia

assess differences in the frequency of hypoglycemia between the 2 study arms

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

evaluate differences in severe hyperglycemia between the 2 study arms

length of hospital stay

differences in LOS between study arms

inflammatory markers

C-reactive protein, interleukin-6, and tumor necrosis factor

Full Information

NCT ID

NCT00394407

First Posted

October 31, 2006

Last Updated

November 20, 2013

Sponsor

Emory University

Collaborators

Sanofi, University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00394407

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Sanofi, University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Hyperglycemia

Keywords

inpatient, diabetes management, insulin therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sliding scale regular insulin

Arm Type

Active Comparator

Arm Description

sliding scale insulin given acqhs

Arm Title

glargine insulin and glulisine insulin

Arm Type

Active Comparator

Arm Description

glargine basal insulin once a day with prandial glulisine insulin tid

Intervention Type

Drug

Intervention Name(s)

sliding scale regular insulin

Other Intervention Name(s)

Novolin-R

Intervention Description

SSRI acqhs

Intervention Type

Drug

Intervention Name(s)

glargine basal insulin and glulisine prandial insulin

Other Intervention Name(s)

Lantus inuslin, Apidra insulin

Intervention Description

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

Primary Outcome Measure Information:

Title

blood glucose control

Description

Differences in BG control will be assessed between the 2 arms acqhs and as needed for those patients hospitalized on the non-medical floors

Time Frame

During hospitalization

Secondary Outcome Measure Information:

Title

frequency of hypoglycemia

Description

assess differences in the frequency of hypoglycemia between the 2 study arms

Time Frame

during the hospitalization

Title

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

Description

evaluate differences in severe hyperglycemia between the 2 study arms

Time Frame

during the hospitalization

Title

length of hospital stay

Description

differences in LOS between study arms

Time Frame

during hospitalization

Title

inflammatory markers

Description

C-reactive protein, interleukin-6, and tumor necrosis factor

Time Frame

during hospitalization

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillermo E Umpierrez, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami School of Medicine

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33124

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17513708

Citation

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.

Results Reference

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

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