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The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.
The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Aspart for BG > 140 mg/dL | Active Comparator | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL. |
|
| Insulin Aspart for BG > 260 mg/dL | Active Comparator | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glargine | Drug | Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day. Daily insulin dose will be adjusted as follow:
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily BG Levels | Blood glucose (BG) will be measured, and mean daily BG levels will be calculated. | 5 days (average time of discharge from the hospital) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Levels Before Lunch | The blood glucose levels will be assessed prior to lunch using a glucose meter. | 5 days (average time of discharge from the hospital) |
| Mean Blood Glucose Levels at Bedtime |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Priyathama Vellanki, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35675498 | Derived | Vellanki P, Cardona S, Galindo RJ, Urrutia MA, Pasquel FJ, Davis GM, Fayfman M, Migdal A, Peng L, Umpierrez GE. Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study. Diabetes Care. 2022 Oct 1;45(10):2217-2223. doi: 10.2337/dc21-1606. |
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A total of 226 subjects consented from October 2015 to December 2019. Two subjects withdrew or left the hospital prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Aspart for BG > 140 mg/dL | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL. |
| FG001 | Insulin Aspart for BG > 260 mg/dL | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Aspart for BG > 140 mg/dL | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL. |
| 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 Daily BG Levels | Blood glucose (BG) will be measured, and mean daily BG levels will be calculated. | Posted | Mean | Standard Deviation | mg/dL | 5 days (average time of discharge from the hospital) |
|
1 week
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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 | Insulin Aspart for BG > 140 mg/dL | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Priyathama Vellanki | Emory University | 404-251-8957 | priyathama.vellanki@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2017 | Dec 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| 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 |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
|
| Insulin aspart | Drug | Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held. Daily insulin dose will be adjusted as follow:
|
|
|
| Supplemental insulin aspart | Drug | Insulin aspart will be administered following the supplemental insulin scale protocol. For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows:
For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:
|
|
|
The blood glucose levels will be assessed at bedtime using a glucose meter.
| 5 days (average time of discharge from the hospital) |
| Mean Blood Glucose Levels Before Dinner | The blood glucose levels will be assessed before dinner using a glucose meter. | 5 days (average time of discharge from the hospital) |
| Number of Hypoglycemia Events | The number of occurrences of hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded. | 5 days (average time of discharge from the hospital) |
| Incidence of Hyperglycemia | The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded. | 5 days (average time of discharge from the hospital) |
| Number of Blood Glucose Readings Within 100-140 mg/dL Range | The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded. | 5 days (average time of discharge from the hospital) |
| Average Number of Days of Hospital Stay | The average number of days in the hospital for subjects will be calculated. | 5 days (average time of discharge from the hospital) |
| Mortality | The total number of subject deaths during hospital stay will be recorded. | 5 days (average time of discharge from the hospital) |
| Number of Subjects That Experienced Hospital Complications | The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury [rise of serum creatinine >0.5 mg/dL (or 50%) of baseline value]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria. | 5 days (average time of discharge from the hospital) |
| Mean Daily Dose of Insulin | Daily dose of insulin will be recorded | 5 days (average time of discharge from the hospital) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Received Steroids |
|
| Discharged same day |
|
| Did not receive insulin |
|
| BG001 |
| Insulin Aspart for BG > 260 mg/dL |
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Blood Glucose Levels Before Lunch | The blood glucose levels will be assessed prior to lunch using a glucose meter. | Posted | Mean | Standard Deviation | mg/dL | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Mean Blood Glucose Levels at Bedtime | The blood glucose levels will be assessed at bedtime using a glucose meter. | Posted | Mean | Standard Deviation | mg/dl | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Mean Blood Glucose Levels Before Dinner | The blood glucose levels will be assessed before dinner using a glucose meter. | Posted | Mean | Standard Deviation | mg/dL | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Number of Hypoglycemia Events | The number of occurrences of hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded. | Posted | Number | number of events | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Incidence of Hyperglycemia | The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded. | Posted | Number | number of events | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Number of Blood Glucose Readings Within 100-140 mg/dL Range | The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded. | Posted | Number | number of readings | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Average Number of Days of Hospital Stay | The average number of days in the hospital for subjects will be calculated. | Posted | Median | Inter-Quartile Range | days | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Mortality | The total number of subject deaths during hospital stay will be recorded. | Posted | Count of Participants | Participants | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Number of Subjects That Experienced Hospital Complications | The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury [rise of serum creatinine >0.5 mg/dL (or 50%) of baseline value]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria. | Posted | Count of Participants | Participants | 5 days (average time of discharge from the hospital) |
|
|
|
| Secondary | Mean Daily Dose of Insulin | Daily dose of insulin will be recorded | Posted | Mean | Standard Deviation | units/day | 5 days (average time of discharge from the hospital) |
|
|
|
| 1 |
| 108 |
| 0 |
| 108 |
| 11 |
| 108 |
| EG001 | Insulin Aspart for BG > 260 mg/dL | Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL. | 0 | 107 | 0 | 107 | 12 | 107 |
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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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 |