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| ID | Type | Description | Link |
|---|---|---|---|
| e5062 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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High blood glucose levels in surgical patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. In patients who have undergone surgery, high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital complications than treatment with regular insulin per sliding scale (SSRI). The present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment of patients with diabetes by the FDA.
Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta, Georgia. A total of ~94 patients will be recruited at each institution.
A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial will be completed in order to determine differences in hospitalization cost between basal bolus insulin and SSI regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG > 140 |
|
| 2 | Active Comparator | Sliding scale regular insulin four-times daily achs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glargine | Drug | Insulin glargine once daily SQ |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Concentration | blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment | hospital stay days 2-10 |
| Measure | Description | Time Frame |
|---|---|---|
| # Participants With Hypoglycemic Events | number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl) | hospital stay days 2-10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21228246 | Result | Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12. | |
| 19366972 |
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Exclusion criteria included hyperglycemia without a known history of diabetes, cardiac surgery, clinically relevant hepatic disease or impaired renal function (serum creatinine ≥3.0 mg/dL), history of diabetic ketoacidosis (20), pregnancy, and any mental condition rendering the subject unable to give informed consent.
Enrolled patients with a BG 140-400 mg/dL with DM for more than 3 months,aged 18-80 yo, treated with diet alone, any combination of oral antidiabetic agents, or lowdose insulin in 2008-2009. Study was conducted at Grady Memorial Hospital,Emory University Hospitaland the Veterans Administration Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Basal Bolus | Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals. |
| FG001 | SSRI | Sliding scale regular insulin four-times daily if blood glucose > 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Basal Bolus | Glargine and rapid-acting mealtime insulin plus supplemental glulisine |
| BG001 | SSRI | Sliding scale regular insulin four-times daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | # Participants With Hypoglycemic Events | number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl) | Posted | Number | participants | hospital stay days 2-10 |
|
|
during hospital days 1-10
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Basal Bolus | Glargine and rapid-acting mealtime insulin plus supplemental glulisine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia < 70 mg/dl | Metabolism and nutrition disorders | hypoglycemia | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez | Emory Univ SOM | 4047781665 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007328 | Insulin |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Regular insulin | Drug | Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO |
|
|
| Insulin glulisine | Drug | scheduled glulisine given SQ at mealtime TID; none given if patient NPO |
|
|
| Atlanta |
| Georgia |
| 30324 |
| United States |
| Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Ceron M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. |
| Withdrawal by Subject |
|
| cancelled surgery |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Mean Blood Glucose Concentration | blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment | Posted | Mean | Standard Deviation | mg/dl | hospital stay days 2-10 |
|
|
|
| 24 |
| 104 |
| 0 |
| 104 |
| EG001 | SSRI | Sliding scale regular insulin four-times daily. | 5 | 107 | 0 | 107 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |