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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.
The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspart flexible dose | Experimental | aspart dose determined based upon carbohydrate intake. |
|
| Aspart fixed dose | Active Comparator | fixed meal dose of aspart (based upon weight or total daily insulin dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspart fixed dose | Drug | fixed dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose | Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3 | day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Glucose | Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3. | day 3 |
| Hypoglycemia | Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl) |
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Inclusion Criteria:
Exclusion Criteria:
• Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).
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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 | Flexible Dose | Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). |
| FG001 | Fixed Dose | Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flexible Dose | aspart dose determined based upon carbohydrate intake. |
| BG001 | Fixed Dose | fixed meal dose of aspart (based upon weight or total daily insulin dose) |
| 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 Glucose | Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3 | Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status. | Posted | Mean | Standard Deviation | mg/dl | day 3 |
|
72 hours
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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 | Flexible Dose | aspart dose determined based upon carbohydrate intake. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia (BG <70 mg/dl) | Endocrine disorders | Systematic Assessment |
Miscalculation of meal doses, mistimed doses, lack of complete documentation of carbohydrate intake, and dosing conducted by an experienced clinician may have contributed to the findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Dungan | The Ohio State University | 614-685-3333 | kathleen.dungan@osumc.edu |
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| 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 |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Aspart flexible dose | Drug | dose based upon carbohydrate intake and total daily requirements |
|
|
| 72 hour |
| Change in Glucose | Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1. | 72 hour |
| Treatment Satisfaction | treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score. | day 3 |
| 1,5-anhydroglucitol Change | change in short-term measure of glycemia | day 1 to day 3 |
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Postprandial Glucose | Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3. | Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status. | Posted | Mean | Standard Deviation | mg/dl | day 3 |
|
|
|
| Secondary | Hypoglycemia | Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl) | Posted | Number | participants | 72 hour |
|
|
|
| Secondary | Change in Glucose | Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1. | intention to treat population | Posted | Mean | Standard Deviation | mg/dl | 72 hour |
|
|
|
| Secondary | Treatment Satisfaction | treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score. | all participants who completed the survey | Posted | Mean | Standard Deviation | points on a scale | day 3 |
|
|
|
| Secondary | 1,5-anhydroglucitol Change | change in short-term measure of glycemia | subjects with complete data | Posted | Mean | Standard Deviation | mcg/ml | day 1 to day 3 |
|
|
|
| 0 |
| 62 |
| 24 |
| 62 |
| EG001 | Fixed Dose | fixed meal dose of aspart (based upon weight or total daily insulin dose) | 0 | 59 | 14 | 59 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |