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Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.
Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glargine plus supplemental glulisine | Active Comparator | Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. |
|
| 70/30 insulin plus supplemental lunch insulin | Active Comparator | Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. |
|
| Sliding Scale insulin (SSI) | Active Comparator | For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regular insulin | Drug |
| ||
| 70/30 insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. | during hospital stay which is expected to be average 3 weeks | |
| Mean BG After First Day of Hospitalization | after first day of hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Developed Hypoglycemic Events | Hypoglycemic episodes are classified as major (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness), or minor (BG between 40 and 59 mg/dL) events. | during hospital stay which is expected to be average 3 weeks |
| Number of Patients Developed Episodes of Severe Hyperglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the department of internal medicine, Cairo University teaching hospitals, | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17513708 | Background | 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. | |
| 19017758 | Background |
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a known history of type 2 DM for longer than 3 months admitted to general medicine wards, age between 18 - 64 year old, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glargine Plus Supplemental Glulisine | Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine |
| FG001 | 70/30 Insulin Plus Supplemental Lunch Insulin | Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin |
| FG002 | Sliding Scale Insulin (SSI) | For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glargine Plus Supplemental Glulisine | Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. | Posted | Mean | Standard Deviation | mg/dL | during hospital stay which is expected to be average 3 weeks |
|
during hospital stay which is expected to be 3 weeks
Major hypoglycemia (BG ≤ 40 mg/dL) associated with impaired mental status or loss of consciousness
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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 | Glargine Plus Supplemental Glulisine | Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG > 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| major hypoglycemia | Nervous system disorders | Serious | Systematic Assessment | Major Hypoglycemic episodes (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hyperglcemia eposide | Nervous system disorders | Serious | Systematic Assessment | severe hyperglycemia episode (BG > 300 mg/dL) |
self funded
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eman Said Sayed | Cairo University | 01001186079 | 002 | gaviota_3011@hotmail.com |
Not provided
| ID | Term |
|---|---|
| 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 |
|---|---|
| D007328 | Insulin |
| D000069036 | Insulin Glargine |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
|
| Glargine | Drug |
|
|
| glulisine | Drug |
|
|
Hyperglycemic events are defined as BG > 300 mg/dL. |
| during hospital stay which is expected to be average 3 weeks |
| Mortality Rate | during the hospital stay which is expected to be average 3 weeks |
| Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18. |
| BG001 | 70/30 Insulin Plus Supplemental Lunch Insulin | Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin |
| BG002 | Sliding Scale Insulin (SSI) | For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | Kg |
|
| BMI | Mean | Standard Deviation | Kg/m2 |
|
| OG001 | 70/30 Insulin Plus Supplemental Lunch Insulin | Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin |
| OG002 | Sliding Scale Insulin (SSI) | For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin |
|
|
| Secondary | Number of Patients Developed Hypoglycemic Events | Hypoglycemic episodes are classified as major (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness), or minor (BG between 40 and 59 mg/dL) events. | Posted | Number | participants | during hospital stay which is expected to be average 3 weeks |
|
|
|
| Secondary | Number of Patients Developed Episodes of Severe Hyperglycemia | Hyperglycemic events are defined as BG > 300 mg/dL. | Posted | Number | participants | during hospital stay which is expected to be average 3 weeks |
|
|
|
| Secondary | Mortality Rate | Posted | Number | participants | during the hospital stay which is expected to be average 3 weeks |
|
|
|
| Primary | Mean BG After First Day of Hospitalization | Posted | Mean | Standard Deviation | mg/dL | after first day of hospitalization |
|
|
|
| 2 |
| 19 |
| 10 |
| 19 |
| EG001 | 70/30 Insulin Plus Supplemental Lunch Insulin | Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG > 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin | 0 | 21 | 4 | 21 |
| EG002 | Sliding Scale Insulin (SSI) | For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG > 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin | 0 | 22 | 15 | 21 |
|
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
|