Management of Hyperglycemia in the ER: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care

NCT ID: NCT00663624

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

Brief Summary

In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis and many patients with uncontrolled diabetes are admitted to the hospital after initial evaluation in the ED. Currently there are no guidelines in the US for the management of hyperglycemia in patients with diabetes during the duration of evaluation and treatment in the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. In this study, we hypothesize that a defined two-step approach to the management of high blood sugars with insulin injections initiated in the ED may decrease length of stay in the ED or hospital, improve clinical outcome and prevent some hospital complications. In the first phase, patients with diabetes admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive scheduled aspart or the usual care as dictated by the ED physicians. In the second phase, patients enrolled in the first phase that are subsequently admitted to the hospital will receive a combination of detemir and aspart insulin or usual care as dictated by the Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine.

This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120 patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo Nordisk.

Conditions

Diabetes

Study Design

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

Study Groups

Experimental

Subcutaneous aspart insulin every 2 hours

Group Type: EXPERIMENTAL

aspart insulin

Intervention Type: DRUG

subcutaneous aspart insulin every 2 hours

Active Comparator

Usual care as prescribed by the ED physicians

Group Type: PLACEBO_COMPARATOR

Usual care as prescribed by the ED physicians.

Intervention Type: DRUG

Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine

Interventions

aspart insulin

subcutaneous aspart insulin every 2 hours

Intervention Type: DRUG

Usual care as prescribed by the ED physicians.

Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects meeting all of the following criteria will be considered for enrollment into the study:
• Males or females between the ages of 18 and 80 years admitted to a general medical service.
• A known history of type 2 diabetes mellitus > 3 months, receiving diet management, any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
• Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive serum or urinary ketones).

Exclusion Criteria

• Subjects with increased blood glucose concentration, but without a known history of diabetes.
• Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
• Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course.
• History of current drug or alcohol abuse.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Inability to give informed consent
• Female patients who are pregnant or are breast feeding
• Patients who have clinically significant liver disease with ALT/AST > 3 X the upper range of normal
• Patients with serum creatinine ≥3.5 mg/dL for males or ≥ 3.0 mg/dL for females or currently treated with dialysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Dawn Smiley MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Smiley, MD

Role: PRINCIPAL_INVESTIGATOR

Emory SOM

Countries

United States

Other Identifiers

e8143

Identifier Type: -

Identifier Source: secondary_id

IRB00008143

Identifier Type: -

Identifier Source: org_study_id