Type 2 Diabetes
Conditions
Keywords
Long-acting insulin analog
Brief summary
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.
Detailed description
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.
Interventions
DRUGDegludec
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.
DRUGGlargine
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.
DRUGAspart
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.
Sponsors
Novo Nordisk A/S
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females \> 18 years of age who are admitted to a general medicine or surgical service 2. A known history of T2D treated either with diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) or insulin therapy except for degludec and glargine U300 3. Subjects with diet alone and HbA1c\>7.0% 4. Medical and surgical patients expected to be admitted length of stay (LOS) longer than 2 days 5. Subjects must have a randomization BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalent (mEq)/L, potential of hydrogen (pH) \< 7.30, or positive serum or urinary ketones) 6. Signed, informed consent and HIPAA documentation prior to any study procedures
Exclusion criteria
1. Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia) 2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c \<7% 3. Admission or pre-randomization BG≥400 mg/dL 4. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria 5. Patients treated with degludec or glargine U300, or with long-acting weekly GLP-1 RA (weekly exenatide, dulaglutide or albiglutide) 6. Patients with acute critical or surgical illness admitted to the ICU except for observation (\<24 hours and did not require vasopressors and/or mechanical ventilation) 7. Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day), or impaired renal function (eGFR\< 30 ml/min), or congestive heart failure (NYHA- IV) 8. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study 9. Female subjects who are pregnant or breast feeding at time of enrollment into the study 10. Known or suspected allergy to trial medication(s), excipients, or related products 11. Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Daily Blood Glucose Concentration in Hospitalized Patients | Baseline, up to the first 10 days of therapy | 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. |
| Mean Daily Blood Glucose Concentration in Discharged Patients. | Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized | During the first 10 days of therapy | 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. |
| Daily Dose of Insulin in Hospitalized Patients | During the first 10 days of therapy | 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. |
| Hemoglobin A1c (HbA1c) in Discharged Patients | 4 and 12 weeks after hospital discharge | 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. |
| Number of Hypoglycemia Episodes in Discharged Patients | Up to 12 weeks after hospital discharge | 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. |
| Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients | Up to 12 weeks after hospital discharge | 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. |
| Number of Episodes of Severe Hyperglycemia in Discharged Patients | Up to 12 weeks after hospital discharge | 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. |
| Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients | During the first 10 days of therapy | 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. |
| Number of Participants With an Episode of Hypoglycemia While Hospitalized | During the first 10 days of therapy | 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. |
| Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized | During the first 10 days of therapy | 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. |
| Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized | During the first 10 days of therapy | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died During Hospitalization | Duration of hospital stay (an average of 10 days) | Hospital mortality is evaluated as the number of deaths among participants during hospitalization. |
| Number of Participants Experiencing Acute Kidney Injury in Discharged Patients | Up to 12 weeks after hospital discharge | 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. |
| Number of Participants With Acute Kidney Injury During Hospitalization | During the first 10 days of therapy | 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. |
| Length of Hospital Stay | Duration of hospital stay (an average of 10 days) | The length of hospital in days is presented here. |
| Number of Participants Experiencing Cardiac Complications During Hospitalization | During the first 10 days of therapy | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| 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. | 79 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive study medication | 1 | 2 |
| Overall Study | Discharged within 48 hours of study medication | 8 | 6 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Degludec | Glargine | Total |
|---|---|---|---|
| Age, Continuous | 55.6 Years STANDARD_DEVIATION 12 | 56.7 Years STANDARD_DEVIATION 10 | 56.2 Years STANDARD_DEVIATION 11 |
| Body Mass Index | 36 kg/m^2 STANDARD_DEVIATION 9 | 36 kg/m^2 STANDARD_DEVIATION 12 | 36 kg/m^2 STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 69 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Home diabetes treatment Glucagon-like peptide-1 receptor agonists (GLP-1RA) | 0 Participants | 1 Participants | 1 Participants |
| Home diabetes treatment Insulin only | 30 Participants | 32 Participants | 62 Participants |
| Home diabetes treatment Insulin plus oral diabetic agent | 27 Participants | 21 Participants | 48 Participants |
| Home diabetes treatment No treatment | 7 Participants | 10 Participants | 17 Participants |
| Home diabetes treatment Oral diabetic agents | 18 Participants | 15 Participants | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 58 Participants | 56 Participants | 114 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 18 Participants | 34 Participants |
| Region of Enrollment United States | 82 Participants | 79 Participants | 161 Participants |
| Sex: Female, Male Female | 35 Participants | 25 Participants | 60 Participants |
| Sex: Female, Male Male | 47 Participants | 54 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 82 | 1 / 79 |
| other Total, other adverse events | 3 / 82 | 3 / 79 |
| serious Total, serious adverse events | 3 / 82 | 3 / 79 |
Outcome results
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.
Time frame: Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge
Population: This analysis includes participants completing the outpatient study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degludec | Mean Daily Blood Glucose Concentration in Discharged Patients. | 4 week post-discharge up to the 12 week post-discharge study visit | 148.7 mg/dL | Standard Deviation 43.6 |
| Degludec | Mean Daily Blood Glucose Concentration in Discharged Patients. | Day after discharge up to the 4 week post-discharge study visit | 157.0 mg/dL | Standard Deviation 46.4 |
| Glargine | Mean Daily Blood Glucose Concentration in Discharged Patients. | Day after discharge up to the 4 week post-discharge study visit | 143.0 mg/dL | Standard Deviation 42.5 |
| Glargine | Mean Daily Blood Glucose Concentration in Discharged Patients. | 4 week post-discharge up to the 12 week post-discharge study visit | 133.8 mg/dL | Standard Deviation 44.2 |
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.
Time frame: Baseline, up to the first 10 days of therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degludec | Mean Daily Blood Glucose Concentration in Hospitalized Patients | Baseline | 219.50 mg/dL | Standard Deviation 50.21 |
| Degludec | Mean Daily Blood Glucose Concentration in Hospitalized Patients | Day 1 up to Day 10 | 179.75 mg/dL | Standard Deviation 38.45 |
| Glargine | Mean Daily Blood Glucose Concentration in Hospitalized Patients | Baseline | 218.19 mg/dL | Standard Deviation 54.56 |
| Glargine | Mean Daily Blood Glucose Concentration in Hospitalized Patients | Day 1 up to Day 10 | 180.67 mg/dL | Standard Deviation 45.1 |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degludec | Daily Dose of Insulin in Hospitalized Patients | Basal Insulin | 30 International Units of insulin | Standard Deviation 13 |
| Degludec | Daily Dose of Insulin in Hospitalized Patients | Prandial Insulin | 11 International Units of insulin | Standard Deviation 9 |
| Degludec | Daily Dose of Insulin in Hospitalized Patients | Total Daily Dose of Insulin | 56 International Units of insulin | Standard Deviation 24 |
| Glargine | Daily Dose of Insulin in Hospitalized Patients | Basal Insulin | 30 International Units of insulin | Standard Deviation 18 |
| Glargine | Daily Dose of Insulin in Hospitalized Patients | Prandial Insulin | 12 International Units of insulin | Standard Deviation 11 |
| Glargine | Daily Dose of Insulin in Hospitalized Patients | Total Daily Dose of Insulin | 60 International Units of insulin | Standard Deviation 36 |
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.
Time frame: 4 and 12 weeks after hospital discharge
Population: This analysis includes participants completing the outpatient study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degludec | Hemoglobin A1c (HbA1c) in Discharged Patients | 4 weeks post-discharge | 8.3 percent of RBCs with glycated hemoglobin | Standard Deviation 1.4 |
| Degludec | Hemoglobin A1c (HbA1c) in Discharged Patients | 12 weeks post-discharge | 8.2 percent of RBCs with glycated hemoglobin | Standard Deviation 1.9 |
| Glargine | Hemoglobin A1c (HbA1c) in Discharged Patients | 4 weeks post-discharge | 8.0 percent of RBCs with glycated hemoglobin | Standard Deviation 1.4 |
| Glargine | Hemoglobin A1c (HbA1c) in Discharged Patients | 12 weeks post-discharge | 7.4 percent of RBCs with glycated hemoglobin | Standard Deviation 1.6 |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Degludec | Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients | 758 Blood Glucose Point-of-Care Test |
| Glargine | Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients | 789 Blood Glucose Point-of-Care Test |
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.
Time frame: Up to 12 weeks after hospital discharge
Population: This analysis includes participants completing the outpatient study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degludec | Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients | 1 episodes of significant hypoglycemia |
| Glargine | Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients | 1 episodes of significant hypoglycemia |
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.
Time frame: Up to 12 weeks after hospital discharge
Population: This analysis includes participants completing the outpatient study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degludec | Number of Episodes of Severe Hyperglycemia in Discharged Patients | 211 episodes of severe hyperglycemia |
| Glargine | Number of Episodes of Severe Hyperglycemia in Discharged Patients | 55 episodes of severe hyperglycemia |
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.
Time frame: Up to 12 weeks after hospital discharge
Population: This analysis includes participants completing the outpatient study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degludec | Number of Hypoglycemia Episodes in Discharged Patients | 16 episodes of hypoglycemia |
| Glargine | Number of Hypoglycemia Episodes in Discharged Patients | 19 episodes of hypoglycemia |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized | 3 Participants |
| Glargine | Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized | 1 Participants |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants With an Episode of Hypoglycemia While Hospitalized | 14 Participants |
| Glargine | Number of Participants With an Episode of Hypoglycemia While Hospitalized | 15 Participants |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized | 52 Participants |
| Glargine | Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized | 47 Participants |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized | 0 Participants |
| Glargine | Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized | 0 Participants |
Other Pre-specified
Length of Hospital Stay
The length of hospital in days is presented here.
Time frame: Duration of hospital stay (an average of 10 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degludec | Length of Hospital Stay | 6.7 days |
| Glargine | Length of Hospital Stay | 7.5 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.
Time frame: Up to 12 weeks after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants Experiencing Acute Kidney Injury in Discharged Patients | 1 Participants |
| Glargine | Number of Participants Experiencing Acute Kidney Injury in Discharged Patients | 0 Participants |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants Experiencing Cardiac Complications During Hospitalization | 0 Participants |
| Glargine | Number of Participants Experiencing Cardiac Complications During Hospitalization | 0 Participants |
Other Pre-specified
Number of Participants Who Died During Hospitalization
Hospital mortality is evaluated as the number of deaths among participants during hospitalization.
Time frame: Duration of hospital stay (an average of 10 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants Who Died During Hospitalization | 0 Participants |
| Glargine | Number of Participants Who Died During Hospitalization | 1 Participants |
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.
Time frame: During the first 10 days of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Degludec | Number of Participants With Acute Kidney Injury During Hospitalization | 5 Participants |
| Glargine | Number of Participants With Acute Kidney Injury During Hospitalization | 10 Participants |