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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.
This study will enroll 180 hospitalized patients with Type 2 diabetes and moderate to end stage renal insufficiency (estimated glomerular filtration rate is < 30 ml/min/1.73m2 or dialysis) in the Chicagoland area. Participants will be randomized into 1 of 2 protocols after hospital admission. Blood glucose levels will be obtained before meals, at bedtime and whenever necessary for any signs or symptoms of hypoglycemia. The primary endpoint will be the percentage of blood glucose levels reaching goal of 80-180mg/dl. A secondary endpoint will be the percentage of hypoglycemic events, defined as blood glucose values < 60 mg/dl. In addition the percentage of glucose levels within the goal range of 80-180mg.dl will be further separated into excellent control (80-140mg/dl) and acceptable control (141-180mg/dl).
The 2 study groups will be:
All oral agents will be discontinued on admission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 units/kg | Active Comparator | Participants randomized to this arm will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. |
|
| 0.25 units/kg | Experimental | Participants randomized to this arm will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 units/kg daily insulin | Drug | Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Blood Glucose Over 6 Days | Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts. | 6 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter | At the end of the study, the number of participants who experience at least one blood glucose level below 70 milligrams per deciliter (mg/dL) is compared between the two treatment cohorts | 6 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Ann Emanuele, MD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Medical Center | Chicago | Illinois | 60611 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18308683 | Background | American Diabetes Association. Economic costs of diabetes in the U.S. In 2007. Diabetes Care. 2008 Mar;31(3):596-615. doi: 10.2337/dc08-9017. | |
| 15855558 | Background | Baldwin D, Villanueva G, McNutt R, Bhatnagar S. Eliminating inpatient sliding-scale insulin: a reeducation project with medical house staff. Diabetes Care. 2005 May;28(5):1008-11. doi: 10.2337/diacare.28.5.1008. |
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There are no plans to make individual participant data available to other researchers
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Recruitment for this study took place at Loyola University Medical Center (Maywood, IL), Rush University Medical Center (Chicago, IL), and Northwestern University Medical Center (Chicago, IL) between January 2009 and May 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5 Units/kg | Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine. |
| FG001 | 0.25 Units/kg | Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population comprises all patients who were randomized and completed all study activities
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5 Units/kg | Participants randomized to this arm will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. 0.5 units/kg daily insulin: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as 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 | Average Blood Glucose Over 6 Days | Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts. | The analysis population for the primary outcome comprises all participants who were randomized and completed all study activities | Posted | Mean | Standard Deviation | milligrams per deciliter | 6 Days |
|
Adverse event data were collected for 2 years, 3 months
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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 | 0.5 Units/kg | Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Baldwin, MD | Rush University Medical Center | 312-942-2813 | david_baldwin@rush.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Eligible participants are randomized to one of the two dosing groups using a 1:1 allocation
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|
| 0.25 units/kg daily insulin | Drug | Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. |
|
|
| Chicago |
| Illinois |
| 60612 |
| United States |
| Loyola University Hospital | Maywood | Illinois | 60153 | United States |
| 17002924 | Background | DeSantis AJ, Schmeltz LR, Schmidt K, O'Shea-Mahler E, Rhee C, Wells A, Brandt S, Peterson S, Molitch ME. Inpatient management of hyperglycemia: the Northwestern experience. Endocr Pract. 2006 Sep-Oct;12(5):491-505. doi: 10.4158/EP.12.5.491. |
| 17229943 | Background | Schmeltz LR, DeSantis AJ, Thiyagarajan V, Schmidt K, O'Shea-Mahler E, Johnson D, Henske J, McCarthy PM, Gleason TG, McGee EC, Molitch ME. Reduction of surgical mortality and morbidity in diabetic patients undergoing cardiac surgery with a combined intravenous and subcutaneous insulin glucose management strategy. Diabetes Care. 2007 Apr;30(4):823-8. doi: 10.2337/dc06-2184. Epub 2007 Jan 17. |
| 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 | 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. |
| 21228246 | Background | 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. |
| 21661100 | Background | Bernard JB, Munoz C, Harper J, Muriello M, Rico E, Baldwin D. Treatment of inpatient hyperglycemia beginning in the emergency department: a randomized trial using insulins aspart and detemir compared with usual care. J Hosp Med. 2011 May;6(5):279-84. doi: 10.1002/jhm.866. |
| 22090269 | Background | Murad MH, Coburn JA, Coto-Yglesias F, Dzyubak S, Hazem A, Lane MA, Prokop LJ, Montori VM. Glycemic control in non-critically ill hospitalized patients: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2012 Jan;97(1):49-58. doi: 10.1210/jc.2011-2100. Epub 2011 Nov 16. |
| 14747243 | Background | Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. doi: 10.2337/diacare.27.2.553. No abstract available. |
| 19429873 | Background | Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available. |
| 22223765 | Background | Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, Seley JJ, Van den Berghe G; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098. |
| 3534567 | Background | Fischer KF, Lees JA, Newman JH. Hypoglycemia in hospitalized patients. Causes and outcomes. N Engl J Med. 1986 Nov 13;315(20):1245-50. doi: 10.1056/NEJM198611133152002. |
| 12912719 | Background | Kagansky N, Levy S, Rimon E, Cojocaru L, Fridman A, Ozer Z, Knobler H. Hypoglycemia as a predictor of mortality in hospitalized elderly patients. Arch Intern Med. 2003 Aug 11-25;163(15):1825-9. doi: 10.1001/archinte.163.15.1825. |
| 17702035 | Background | Varghese P, Gleason V, Sorokin R, Senholzi C, Jabbour S, Gottlieb JE. Hypoglycemia in hospitalized patients treated with antihyperglycemic agents. J Hosp Med. 2007 Jul;2(4):234-40. doi: 10.1002/jhm.212. |
| 19564471 | Background | Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward. Diabetes Care. 2009 Jul;32(7):1153-7. doi: 10.2337/dc08-2127. |
| 20144357 | Background | Bailon RM, Cook CB, Hovan MJ, Hull BP, Seifert KM, Miller-Cage V, Beer KA, Boyle ME, Littman SD, Magallanez JM, Fischenich JM, Harris JK, Scoggins SS, Uy J. Temporal and geographic patterns of hypoglycemia among hospitalized patients with diabetes mellitus. J Diabetes Sci Technol. 2009 Mar 1;3(2):261-8. doi: 10.1177/193229680900300206. |
| 21700919 | Background | Rubin DJ, Rybin D, Doros G, McDonnell ME. Weight-based, insulin dose-related hypoglycemia in hospitalized patients with diabetes. Diabetes Care. 2011 Aug;34(8):1723-8. doi: 10.2337/dc10-2434. Epub 2011 Jun 23. |
| 5635331 | Background | Horton ES, Johnson C, Lebovitz HE. Carbohydrate metabolism in uremia. Ann Intern Med. 1968 Jan;68(1):63-74. doi: 10.7326/0003-4819-68-1-63. No abstract available. |
| 19423569 | Background | Moen MF, Zhan M, Hsu VD, Walker LD, Einhorn LM, Seliger SL, Fink JC. Frequency of hypoglycemia and its significance in chronic kidney disease. Clin J Am Soc Nephrol. 2009 Jun;4(6):1121-7. doi: 10.2215/CJN.00800209. Epub 2009 May 7. |
| 11347749 | Background | Rave K, Heise T, Pfutzner A, Heinemann L, Sawicki PT. Impact of diabetic nephropathy on pharmacodynamic and Pharmacokinetic properties of insulin in type 1 diabetic patients. Diabetes Care. 2001 May;24(5):886-90. doi: 10.2337/diacare.24.5.886. |
| 10740665 | Background | Mak RH. Impact of end-stage renal disease and dialysis on glycemic control. Semin Dial. 2000 Jan-Feb;13(1):4-8. doi: 10.1046/j.1525-139x.2000.00007.x. No abstract available. |
| 12873291 | Background | Biesenbach G, Raml A, Schmekal B, Eichbauer-Sturm G. Decreased insulin requirement in relation to GFR in nephropathic Type 1 and insulin-treated Type 2 diabetic patients. Diabet Med. 2003 Aug;20(8):642-5. doi: 10.1046/j.1464-5491.2003.01025.x. |
| 22699288 | Derived | Baldwin D, Zander J, Munoz C, Raghu P, DeLange-Hudec S, Lee H, Emanuele MA, Glossop V, Smallwood K, Molitch M. A randomized trial of two weight-based doses of insulin glargine and glulisine in hospitalized subjects with type 2 diabetes and renal insufficiency. Diabetes Care. 2012 Oct;35(10):1970-4. doi: 10.2337/dc12-0578. Epub 2012 Jun 14. |
| BG001 | 0.25 Units/kg | Participants randomized to this arm will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. 0.25 units/kg daily insulin: Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Glomerular filtration rate | Mean | Standard Deviation | mL/min/1.73 squared meters |
|
| Years of Diabetes | Mean | Standard Deviation | years |
|
| Glycated hemoglobin | Mean | Standard Deviation | Percentage (%) |
|
| Insulin therapy before admission | Count of Participants | Participants |
|
| Total home daily insulin dose | Mean | Standard Deviation | units of insulin |
|
|
|
|
| Secondary | The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter | At the end of the study, the number of participants who experience at least one blood glucose level below 70 milligrams per deciliter (mg/dL) is compared between the two treatment cohorts | This analysis comprises all participants who were randomized and completed all study activities | Posted | Count of Participants | Participants | 6 Days |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 0.25 Units/kg | Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine. | 0 | 57 | 0 | 57 | 0 | 57 |
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| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |