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| ID | Type | Description | Link |
|---|---|---|---|
| 60016576 | Other Identifier | Other |
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).
High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily |
|
| 2 | Active Comparator | Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily |
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| 3 | Active Comparator | Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detemir | Drug | Detemir dosed at 50% of calculated basal insulin infusion requirements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 | Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3 | day 2, day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) | Number of patients with hypoglycemia (defined as glucose <65 mg/dl) | 48 hours |
| Reversion to Intravenous Insulin for Failure of Glycemic Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Dungan, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 50% Conversion Factor | Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily |
| FG001 | 65% Conversion Factor | Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily |
| FG002 | 80% Conversion Factor | Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 50% Conversion Factor | Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily |
| BG001 | 65% Conversion Factor | Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 | Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3 | intention to treat (ITT) | Posted | Number | participants | day 2, day 3 |
|
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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 | 50% Conversion Factor | Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BG <40 mg/dl | Endocrine disorders | Systematic Assessment | Any BG <40 mg/dl |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Dungan, MD | The Ohio State University | 614-292-3800 | kathleen.dungan@osumc.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Detemir | Drug | Detemir dosed at 65% of calculated basal insulin infusion requirements |
|
| Detemir | Drug | Detemir dosed at 80% of calculated basal insulin infusion requirements |
|
Number of participants who went back on intravenous insulin for failure of glycemic control.
| 72 hours |
| BG002 | 80% Conversion Factor | Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily |
| BG003 | 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 |
|
| 80% Conversion Factor |
Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily |
|
|
| Secondary | Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) | Number of patients with hypoglycemia (defined as glucose <65 mg/dl) | Intention to treat (ITT) | Posted | Number | participants | 48 hours |
|
|
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| Secondary | Reversion to Intravenous Insulin for Failure of Glycemic Control | Number of participants who went back on intravenous insulin for failure of glycemic control. | Posted | Number | participants | 72 hours |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 65% Conversion Factor | Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily | 0 | 29 | 0 | 29 |
| EG002 | 80% Conversion Factor | Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily | 1 | 25 | 1 | 25 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |