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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Hyperglycemia

Intervention / Treatment
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* Drug: sliding scale regular insulin
* Drug: glargine basal insulin and glulisine prandial insulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sliding scale regular insulin<br>sliding scale insulin given acqhs | Drug: sliding scale regular insulin<br>* SSRI acqhs<br>* Other names: Novolin-R;|
| Active Comparator: glargine insulin and glulisine insulin<br>glargine basal insulin once a day with prandial glulisine insulin tid | Drug: glargine basal insulin and glulisine prandial insulin<br>* glargine insulin once a day and glulisine insulin three times a day as long as patient eating<br>* Other names: Lantus inuslin, Apidra insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of hypoglycemia | assess differences in the frequency of hypoglycemia between the 2 study arms | during the hospitalization | 
| frequency of severe hyperglycemia (BG > 400 mg/dl), | evaluate differences in severe hyperglycemia between the 2 study arms | during the hospitalization | 
| length of hospital stay | differences in LOS between study arms | during hospitalization | 
| inflammatory markers | C-reactive protein, interleukin-6, and tumor necrosis factor | during hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inpatient, diabetes management, insulin therapy