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| ID | Type | Description | Link |
|---|---|---|---|
| 791-2006 | Other Identifier | Other |
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. 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.
This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. 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 Rush University Medical Center, Chicago, IL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| detremir + aspart insulin | Experimental | Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously |
|
| NPH + regular insulin | Active Comparator | NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detemir + aspart insulin before meals | Drug | Detemir insulin SQ once daily + aspart insulin SQ before meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean AM BG (mg/dl) | average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2 | during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Hypoglycemic Events | number of patients with hypoglycemic events as defined as BG 40-59 mg/dl | during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Baldwin, MD | Rush University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19017758 | Result | 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. |
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This study was conducted at Grady Memorial Hospital in Atlanta, GA and at Rush University Medical Center, Chicago, IL. IRB approval was given at each center and consent was obtained from all subjects. Patients with a h/o T2DM were recruited in 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Detemir + Aspart | Detemir insulin once daily + aspart insulin before meals |
| FG001 | NPH+Regular | NPH insulin + regular insulin before breakfast and dinner |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Detemir + Aspart | Detemir insulin once daily + aspart insulin before meals |
| BG001 | NPH+Regular | NPH insulin + regular insulin before breakfast and dinner |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean AM BG (mg/dl) | average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2 | Posted | Mean | Standard Deviation | mg/dl | during hospitalization |
|
|
during study period in the hospital
Hypoglycemic event is defined as blood glucose < 60 mg/dl. All serious adverse events were monitored.
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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 | Detemir + Aspart | Detemir insulin once daily + aspart insulin before meals |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez, MD | EUSOM | 4047781665 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D061267 | Insulin Aspart |
| D007336 | Insulin, Isophane |
| D007328 | Insulin |
| D000068880 | Isophane Insulin, Human |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| NPH insulin + regular insulin | Drug | NPH insulin SQ + regular insulin SQ before breakfast and dinner |
|
|
| Chicago |
| Illinois |
| 60612 |
| United States |
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Patients With Hypoglycemic Events | number of patients with hypoglycemic events as defined as BG 40-59 mg/dl | Posted | Number | participants | during hospitalization |
|
|
|
| 15 |
| 67 |
| 0 |
| 67 |
| EG001 | NPH+Regular | NPH insulin + regular insulin before breakfast and dinner | 13 | 63 | 0 | 63 |
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
| D011384 | Proinsulin |
| D061386 | Insulin, Regular, Human |