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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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The purpose of this study is to find out if treatment with degludec insulin when compared to glargine U100 insulin will result in similar blood sugar control in patients with diabetes who are admitted to the hospital and then transition to home after discharge from the hospital.
Degludec is a new generation basal insulin analog with a longer duration of action compared to insulin glargine. Several outpatient trials have reported that treatment with degludec results in comparable improvement in HbA1c levels and in lower rates of hypoglycemia compared to glargine U100 insulin. However, no previous studies have compared the safety and efficacy of the long-acting basal insulin degludec in the inpatient management of patients with diabetes. It is expected that a large number of patients with diabetes will be started on or transitioned to this new insulin formulation so acquiring knowledge on the safety and efficacy of degludec insulin is of great clinical interest. Accordingly, the proposed study will provide novel and clinically useful information on the efficacy (assessed as blood glucose control) and safety (assessed as hypoglycemia) of degludec in the inpatient setting and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D).
Participants will be randomized to receive either a basal bolus with degludec or glargine U100 once daily during hospitalization. All participants will receive aspart insulin before meals. Participants with poorly controlled diabetes during the inpatient portion of the study will be invited to participate in the outpatient portion of the study. Participants in the outpatient portion of the study will be discharged on their preadmission oral antidiabetic medications plus degludec or glargine once daily, based on the study medication they were randomized to take during the inpatient portion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degludec inpatient | Experimental | Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals. |
|
| Glargine U100 inpatient | Active Comparator | Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degludec | Drug | Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner blood glucose (BG) between 100 mg/dL and 180 mg/dL. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Blood Glucose Concentration in Hospitalized Patients | Blood glucose was measured before each meal and at bedtime among hospitalized study participants. Mean daily blood glucose concentration was calculated to determine differences in inpatient glycemic control in general medicine and surgery patients with Type 2 Diabetes (T2D) treated with basal bolus regimen with insulin degludec or glargine once daily plus aspart insulin before meals. A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes. | Baseline, up to the first 10 days of therapy |
| Mean Daily Blood Glucose Concentration in Discharged Patients. | Blood glucose was measured before each meal and at bedtime, after participants were discharged from the hospital. Mean daily blood glucose concentration was calculated to determine differences in outpatient glycemic control in patients with Type 2 Diabetes (T2D) treated with basal bolus regimen with insulin degludec or glargine once daily plus aspart insulin before meals. Information was collected via bi-weekly phone interviews and during the outpatient study visits at Weeks 4 and 12. | Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients | Blood glucose was measured with point-of-care testing before each meal and at bedtime, and the count of blood glucose test results between 70 mg/dL and 180 mg/dL was determined. | During the first 10 days of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Cardiac Complications During Hospitalization | Cardiac complications during hospitalization were examined as a composite of complications, defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, or cardiac arrest. The number of participants experiencing cardiac complications while hospitalized patients is presented here. | During the first 10 days of therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Hospital | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital Clinical Research Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34490700 | Result | Galindo RJ, Pasquel FJ, Vellanki P, Alicic R, Lam DW, Fayfman M, Migdal AL, Davis GM, Cardona S, Urrutia MA, Perez-Guzman C, Zamudio-Coronado KW, Peng L, Tuttle KR, Umpierrez GE. Degludec hospital trial: A randomized controlled trial comparing insulin degludec U100 and glargine U100 for the inpatient management of patients with type 2 diabetes. Diabetes Obes Metab. 2022 Jan;24(1):42-49. doi: 10.1111/dom.14544. Epub 2021 Sep 24. |
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The research team will share individual participant data that underlie the results reported in this study, after deidentification.
Data will be available for sharing starting 6 months after publication and up to 5 years after publication.
Access will be given to researchers who provide a methodologically sound proposal to achieve the aims in their approved proposal. Proposals should be directed to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.
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Participants were recruited from four study sites in the United States: Emory University Hospital and Grady Memorial Hospital in Atlanta, Georgia, Icahn School of Medicine at Mount Sinai in New York, New York, and Providence Medical Research Center in Spokane, Washington. Enrollment began on January 2, 2018 and all follow up was complete by March 1, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Degludec | Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals. Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Participants were treated with an insulin regimen of half of TDD given a as basal insulin once daily and half as aspart divided in three equal doses before meals. Insulin dosage was adjusted daily to maintain a fasting and pre-dinner blood glucose between 100 and 180 mg/dL. |
| FG001 | Glargine | Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals. Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Participants were treated with an insulin regimen of half of TDD given as basal once daily and half as aspart divided in three equal doses before meals. Insulin dosage was adjusted daily to maintain a fasting and pre-dinner blood glucose between 100 and 180 mg/dL. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population includes participants who completed the inpatient portion of the study and had at least two doses of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Degludec | Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals. |
| BG001 | Glargine |
| 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 | Mean Daily Blood Glucose Concentration in Hospitalized Patients | Blood glucose was measured before each meal and at bedtime among hospitalized study participants. Mean daily blood glucose concentration was calculated to determine differences in inpatient glycemic control in general medicine and surgery patients with Type 2 Diabetes (T2D) treated with basal bolus regimen with insulin degludec or glargine once daily plus aspart insulin before meals. A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes. | Posted | Mean | Standard Deviation | mg/dL | Baseline, up to the first 10 days of therapy |
|
Information on adverse events was collected from the time of consent during hospitalization for up to 3 months after hospital discharge.
During hospitalization, electronic medical records were reviewed daily from the time of consent up to discharge. Any complication not present at the time of consent and that arose 48 hours after randomization was considered an adverse event. After discharge, participants were asked about any hospital readmissions and emergency room visits. Electronic medical records were also reviewed to document any hospital readmissions and emergency room visits among all study participants.
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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 | Degludec | Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital readmission for chest pain | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency room visit for blunt chest trauma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guillermo E. Umpierrez | Emory University | (404) 778-1663 | geumpie@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 | Nov 17, 2020 | Sep 27, 2021 | Prot_SAP_000.pdf |
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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 |
|---|---|
| C571886 | insulin degludec |
| D000069036 | Insulin Glargine |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
|
| Glargine | Drug | Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dL and 180 mg/dL. |
|
|
| Aspart | Drug | Aspart insulin will be given in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, aspart insulin dose will be held. |
|
|
| Number of Participants With an Episode of Hypoglycemia While Hospitalized |
Blood glucose (BG) was measured before each meal and at bedtime. The number of participants with at least one hypoglycemic episode, defined as BG of 54 to 70 mg/dL, is presented here. |
| During the first 10 days of therapy |
| Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized | Blood glucose was measured before each meal and at bedtime. The number of participants with at least one episode of clinically significant hypoglycemia, defined as BG < 54 mg/dL, is presented here. | During the first 10 days of therapy |
| Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized | Blood glucose as measured before each meal and at bedtime. The number of participants with at least one episode of severe hypoglycemia, defined as BG < 40 mg/dL, is presented here. | During the first 10 days of therapy |
| Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized | Blood glucose was measured before each meal and at bedtime. The number of participants who experienced at least one episode of severe hyperglycemia, defined as BG > 240 mg/dL, is presented here. | During the first 10 days of therapy |
| Daily Dose of Insulin in Hospitalized Patients | Electronic medical records and nursing records documented the day day and time of insulin administration, including the basal study drug given once daily (degludec or glargine), prandial insulin given before meals (aspart), and supplemental insulin given to correct hyperglycemia. The mean daily doses of basal insulin, prandial insulin, and total daily dose of insulin given to hospitalized patients are presented here. | During the first 10 days of therapy |
| Hemoglobin A1c (HbA1c) in Discharged Patients | The HbA1C test reflects the average of a person's blood glucose levels over the past 3 months by measuring the percentage of red blood cells (RBCs) with glycated hemoglobin (hemoglobin with glucose bonded to it). Participants with HbA1C ≥ 7.5% were followed for 12 weeks after hospital discharge. Samples for HbA1C were drawn at 4 and 12 weeks post-discharge. An HbA1c measurement below 5.7% is considered normal, while a measurement of 6.5% or greater indicates diabetes. | 4 and 12 weeks after hospital discharge |
| Number of Hypoglycemia Episodes in Discharged Patients | Blood glucose was measured before each meal and at bedtime. The number of hypoglycemia episodes, defined as BG < 70 mg/dL, was recorded via bi-weekly phone interviews and during 4 and 12 week outpatient study visits. | Up to 12 weeks after hospital discharge |
| Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients | Blood glucose will be measured before each meal and at bedtime. The number of episodes of clinically significant hypoglycemia, defined as BG < 54 mg/dL, are presented here. | Up to 12 weeks after hospital discharge |
| Number of Episodes of Severe Hyperglycemia in Discharged Patients | Blood glucose was measured before each meal and at bedtime. The number of episodes of severe hyperglycemia, defined as BG > 240 mg/dL, are presented here. | Up to 12 weeks after hospital discharge |
| Number of Participants With Acute Kidney Injury During Hospitalization | Acute kidney injury defined as an increase in serum creatinine ≥ 0.3 mg/dL from baseline or ≥1.5 times baseline creatinine, per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The number of participants experiencing acute kidney injury during hospitalization is presented here. | During the first 10 days of therapy |
| Length of Hospital Stay | The length of hospital in days is presented here. | Duration of hospital stay (an average of 10 days) |
| Number of Participants Who Died During Hospitalization | Hospital mortality is evaluated as the number of deaths among participants during hospitalization. | Duration of hospital stay (an average of 10 days) |
| Number of Participants Experiencing Acute Kidney Injury in Discharged Patients | Acute kidney injury defined as an increase in serum creatinine ≥ 0.3 mg/dL from baseline or ≥1.5 times baseline creatinine, per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The number of participants experiencing acute kidney injury after hospital discharge is presented here. | Up to 12 weeks after hospital discharge |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Providence Medical Research Centre | Spokane | Washington | 99204 | United States |
| Did not receive study medication |
|
Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Home diabetes treatment | Count of Participants | Participants |
|
| OG001 | Glargine | Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals. |
|
|
| Primary | Mean Daily Blood Glucose Concentration in Discharged Patients. | Blood glucose was measured before each meal and at bedtime, after participants were discharged from the hospital. Mean daily blood glucose concentration was calculated to determine differences in outpatient glycemic control in patients with Type 2 Diabetes (T2D) treated with basal bolus regimen with insulin degludec or glargine once daily plus aspart insulin before meals. Information was collected via bi-weekly phone interviews and during the outpatient study visits at Weeks 4 and 12. | This analysis includes participants completing the outpatient study visits. | Posted | Mean | Standard Deviation | mg/dL | Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge |
|
|
|
| Secondary | Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients | Blood glucose was measured with point-of-care testing before each meal and at bedtime, and the count of blood glucose test results between 70 mg/dL and 180 mg/dL was determined. | Posted | Count of Units | Blood Glucose Point-of-Care Test | During the first 10 days of therapy | Blood Glucose Point-of-Care Test | Blood Glucose Point-of-Care Test |
|
|
|
| Secondary | Number of Participants With an Episode of Hypoglycemia While Hospitalized | Blood glucose (BG) was measured before each meal and at bedtime. The number of participants with at least one hypoglycemic episode, defined as BG of 54 to 70 mg/dL, is presented here. | Posted | Count of Participants | Participants | During the first 10 days of therapy |
|
|
|
| Secondary | Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized | Blood glucose was measured before each meal and at bedtime. The number of participants with at least one episode of clinically significant hypoglycemia, defined as BG < 54 mg/dL, is presented here. | Posted | Count of Participants | Participants | During the first 10 days of therapy |
|
|
|
| Secondary | Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized | Blood glucose as measured before each meal and at bedtime. The number of participants with at least one episode of severe hypoglycemia, defined as BG < 40 mg/dL, is presented here. | Posted | Count of Participants | Participants | During the first 10 days of therapy |
|
|
|
| Secondary | Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized | Blood glucose was measured before each meal and at bedtime. The number of participants who experienced at least one episode of severe hyperglycemia, defined as BG > 240 mg/dL, is presented here. | Posted | Count of Participants | Participants | During the first 10 days of therapy |
|
|
|
| Secondary | Daily Dose of Insulin in Hospitalized Patients | Electronic medical records and nursing records documented the day day and time of insulin administration, including the basal study drug given once daily (degludec or glargine), prandial insulin given before meals (aspart), and supplemental insulin given to correct hyperglycemia. The mean daily doses of basal insulin, prandial insulin, and total daily dose of insulin given to hospitalized patients are presented here. | Posted | Mean | Standard Deviation | International Units of insulin | During the first 10 days of therapy |
|
|
|
| Secondary | Hemoglobin A1c (HbA1c) in Discharged Patients | The HbA1C test reflects the average of a person's blood glucose levels over the past 3 months by measuring the percentage of red blood cells (RBCs) with glycated hemoglobin (hemoglobin with glucose bonded to it). Participants with HbA1C ≥ 7.5% were followed for 12 weeks after hospital discharge. Samples for HbA1C were drawn at 4 and 12 weeks post-discharge. An HbA1c measurement below 5.7% is considered normal, while a measurement of 6.5% or greater indicates diabetes. | This analysis includes participants completing the outpatient study visits. | Posted | Mean | Standard Deviation | percent of RBCs with glycated hemoglobin | 4 and 12 weeks after hospital discharge |
|
|
|
| Secondary | Number of Hypoglycemia Episodes in Discharged Patients | Blood glucose was measured before each meal and at bedtime. The number of hypoglycemia episodes, defined as BG < 70 mg/dL, was recorded via bi-weekly phone interviews and during 4 and 12 week outpatient study visits. | This analysis includes participants completing the outpatient study visits. | Posted | Number | episodes of hypoglycemia | Up to 12 weeks after hospital discharge |
|
|
|
| Secondary | Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients | Blood glucose will be measured before each meal and at bedtime. The number of episodes of clinically significant hypoglycemia, defined as BG < 54 mg/dL, are presented here. | This analysis includes participants completing the outpatient study visits. | Posted | Number | episodes of significant hypoglycemia | Up to 12 weeks after hospital discharge |
|
|
|
| Secondary | Number of Episodes of Severe Hyperglycemia in Discharged Patients | Blood glucose was measured before each meal and at bedtime. The number of episodes of severe hyperglycemia, defined as BG > 240 mg/dL, are presented here. | This analysis includes participants completing the outpatient study visits. | Posted | Number | episodes of severe hyperglycemia | Up to 12 weeks after hospital discharge |
|
|
|
| Other Pre-specified | Number of Participants Experiencing Cardiac Complications During Hospitalization | Cardiac complications during hospitalization were examined as a composite of complications, defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, or cardiac arrest. The number of participants experiencing cardiac complications while hospitalized patients is presented here. | Posted | Count of Participants | Participants | During the first 10 days of therapy |
|
|
|
| Other Pre-specified | Number of Participants With Acute Kidney Injury During Hospitalization | Acute kidney injury defined as an increase in serum creatinine ≥ 0.3 mg/dL from baseline or ≥1.5 times baseline creatinine, per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The number of participants experiencing acute kidney injury during hospitalization is presented here. | Posted | Count of Participants | Participants | During the first 10 days of therapy |
|
|
|
| Other Pre-specified | Length of Hospital Stay | The length of hospital in days is presented here. | Posted | Median | Inter-Quartile Range | days | Duration of hospital stay (an average of 10 days) |
|
|
|
| Other Pre-specified | Number of Participants Who Died During Hospitalization | Hospital mortality is evaluated as the number of deaths among participants during hospitalization. | Posted | Count of Participants | Participants | Duration of hospital stay (an average of 10 days) |
|
|
|
| Other Pre-specified | Number of Participants Experiencing Acute Kidney Injury in Discharged Patients | Acute kidney injury defined as an increase in serum creatinine ≥ 0.3 mg/dL from baseline or ≥1.5 times baseline creatinine, per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The number of participants experiencing acute kidney injury after hospital discharge is presented here. | Posted | Count of Participants | Participants | Up to 12 weeks after hospital discharge |
|
|
|
| 1 |
| 82 |
| 3 |
| 82 |
| 3 |
| 82 |
| EG001 | Glargine | Study participants randomized during hospitalization to receive 80% or 100% of their total daily dose (TDD) of outpatient insulin given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals. | 1 | 79 | 3 | 79 | 3 | 79 |
| Hospital readmission for urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Hospital readmission for head injury | Nervous system disorders | Systematic Assessment | Head injury during rehabilitation resulting in coma |
|
| Hospital readmisson for non-healing amputation stump | Infections and infestations | Systematic Assessment |
|
| Hospital readmission for heart failure | Cardiac disorders | Systematic Assessment |
|
| Severe hypoglycemia | Endocrine disorders | Non-systematic Assessment | Hypoglycemia ≤ 40 mg/dL |
|
| Emergency room visit for bilateral knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Emergency room visit for wound infection | Infections and infestations | Systematic Assessment |
|
| Emergency room visit for right eye medial stye | Eye disorders | Systematic Assessment |
|
| Emergency room visit for congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Emergency room visit for orthostatic hypotension | Cardiac disorders | 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 |
| Total Daily Dose of Insulin |
|