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The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.
Several randomized clinical trials done previously in medicine and surgical patients with T2D have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in lower rate of hospital complications. Glargine U300 results in similar improvement but in lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and diabetes in the hospital setting. This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal bolus insulin with glargine U300 and glulisine insulin | Experimental | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. |
|
| Basal bolus insulin with glargine U100 and glulisine insulin | Active Comparator | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine U300 | Drug | Glargine U300 is a new generation long-acting insulin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Blood Glucose Concentration Inpatient | The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay. | up to 10 days (day of hospital discharge) |
| Mean Daily Blood Glucose Concentration After Hospital Discharge | Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated. | assessed from day 11 (day after hospital discharge) up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8% | Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated. | up to 3 months post enrollment |
| Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8% |
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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 Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32273271 | Derived | Pasquel FJ, Lansang MC, Khowaja A, Urrutia MA, Cardona S, Albury B, Galindo RJ, Fayfman M, Davis G, Migdal A, Vellanki P, Peng L, Umpierrez GE. A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial. Diabetes Care. 2020 Jun;43(6):1242-1248. doi: 10.2337/dc19-1940. Epub 2020 Apr 9. |
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Out of 247 consented, 9 were not randomized, 27 failed to start (19 did not receive study medication, 1 had eGFR out of range, 7 had admission BG >400 mg/dl)
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| ID | Title | Description |
|---|---|---|
| FG000 | Basal Bolus Insulin With Glargine U300 and Glulisine Insulin | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. |
| FG001 | Basal Bolus Insulin With Glargine U100 and Glulisine Insulin | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Basal Bolus Insulin With Glargine U300 and Glulisine Insulin | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. |
| 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 Inpatient | The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay. | Posted | Mean | Standard Deviation | mg/dL | up to 10 days (day of hospital discharge) |
|
3 months.
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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 | Basal Bolus Insulin With Glargine U300 and Glulisine Insulin | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroparesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guillermo Umpierrez | Emory University | 404-778-1665 | 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 | Jan 28, 2019 | Mar 11, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2019 | Mar 11, 2020 | ICF_001.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 |
|---|---|
| D000069036 | Insulin Glargine |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Glargine U100 | Drug | Glargine U100 is a long-acting insulin. |
|
|
| Glulisine Insulin | Drug | Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. |
|
|
Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded |
| up to 3 months post enrollment |
| Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days | Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days | Up to 3 days |
| Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days | Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days | Up to 5 days |
| Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days | Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated. | Up to 10 days |
| Percent of Blood Glucose 70-180 Measured by Point of Care Test | Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test | 3 months post enrollment |
| Percent of Subjects With Hypoglycemic Events | Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded. | 3 months post enrollment |
| Percent of Subjects With Severe Hypoglycemia | Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded. | 3 months post enrollment |
| Number of Days of Hospital Stay | The number of days of hospital stay for each subject will be recorded. | Up to 10 days |
| Number Subjects With Cardiac Complications | The number of subjects experiencing cardiac cardiac complications will be recorded. | 3 months post enrollment |
| Number of Patients With Acute Renal Failure | The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine > 0.5 mg/dL from baseline). | 3 months post enrollment |
| Hospital Mortality | Number of hospital deaths that occur. | During hospital stay - up to 10 days |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| BG001 | Basal Bolus Insulin With Glargine U100 and Glulisine Insulin | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Basal Bolus Insulin With Glargine U100 and Glulisine Insulin | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. |
|
|
| Primary | Mean Daily Blood Glucose Concentration After Hospital Discharge | Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated. | The outpatient has less number of participants compared to the in-hospital part due to a1c less tan required for outpatient part, participants not wanting to continue in the discharge part and/or admission to long term facilities where we were not able to administer study medication. | Posted | Mean | Standard Deviation | mg/dL | assessed from day 11 (day after hospital discharge) up to 3 months |
|
|
|
| Secondary | Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8% | Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated. | subjects with HbA1c lower than 8% at admission | Posted | Mean | Standard Deviation | mg/dL | up to 3 months post enrollment |
|
|
|
| Secondary | Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8% | Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded | Patients with admission HbA1c higher than 8% | Posted | Mean | Standard Deviation | mg/dL | up to 3 months post enrollment |
|
|
|
| Secondary | Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days | Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days | Posted | Mean | Standard Deviation | mg/dL | Up to 3 days |
|
|
|
| Secondary | Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days | Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days | Posted | Mean | Standard Deviation | mg/dL | Up to 5 days |
|
|
|
| Secondary | Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days | Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated. | Posted | Mean | Standard Deviation | mg/dL | Up to 10 days |
|
|
|
| Secondary | Percent of Blood Glucose 70-180 Measured by Point of Care Test | Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test | Posted | Mean | Standard Deviation | percentage of BG readings | 3 months post enrollment |
|
|
|
| Secondary | Percent of Subjects With Hypoglycemic Events | Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded. | Posted | Number | percentage of subjects | 3 months post enrollment |
|
|
|
| Secondary | Percent of Subjects With Severe Hypoglycemia | Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded. | Posted | Number | percentage of subjects | 3 months post enrollment |
|
|
|
| Secondary | Number of Days of Hospital Stay | The number of days of hospital stay for each subject will be recorded. | Posted | Median | Inter-Quartile Range | days | Up to 10 days |
|
|
|
| Secondary | Number Subjects With Cardiac Complications | The number of subjects experiencing cardiac cardiac complications will be recorded. | Posted | Count of Participants | Participants | 3 months post enrollment |
|
|
|
| Secondary | Number of Patients With Acute Renal Failure | The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine > 0.5 mg/dL from baseline). | Posted | Count of Participants | Participants | 3 months post enrollment |
|
|
|
| Secondary | Hospital Mortality | Number of hospital deaths that occur. | Posted | Number | events | During hospital stay - up to 10 days |
|
|
|
| 0 |
| 108 |
| 21 |
| 108 |
| 10 |
| 108 |
| EG001 | Basal Bolus Insulin With Glargine U100 and Glulisine Insulin | Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal. | 2 | 103 | 21 | 103 | 18 | 103 |
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Gastroentestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Chronic Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Infection | General disorders | Non-systematic Assessment |
|
| Surgery | General disorders | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Malfunctioning Peripherally Inserted Central Catheter | Surgical and medical procedures | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | Non-systematic Assessment |
|
| Skin graft failure | Immune system disorders | Non-systematic Assessment |
|
| Numbness on right side of body | Nervous system disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ICU admission | General disorders | Non-systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Infection | General disorders | Non-systematic Assessment |
|
| Leg Swelling | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Polysubstance abuse | Psychiatric disorders | Non-systematic Assessment |
|
| Skin Graft revision | Surgical and medical procedures | Non-systematic Assessment |
|
| Scrotal Bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Social (homelessness) | Social circumstances | Non-systematic Assessment |
|
| Trauma | General disorders | Non-systematic Assessment |
|
| Tremors | General disorders | Non-systematic Assessment |
|
| Wound Check | Surgical and medical procedures | Non-systematic Assessment |
|
| Cerumen Impaction | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chronic heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Cough | 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 |