Trial Outcomes & Findings for Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes (NCT NCT03336528)

NCT ID: NCT03336528

Last Updated: 2022-03-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: Baseline, up to the first 10 days of therapy
• Results posted on: 2022-03-31

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	92	88
Overall Study Participated in Optional Outpatient Study	72	59
Overall Study COMPLETED	82	79
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Measure	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.	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.
Overall Study Protocol Violation	1	1
Overall Study Discharged within 48 hours of study medication	8	6
Overall Study Did not receive study medication	1	2

Baseline Characteristics

Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.	Total n=161 Participants Total of all reporting groups
Age, Continuous	55.6 Years STANDARD_DEVIATION 12 • n=5 Participants	56.7 Years STANDARD_DEVIATION 10 • n=7 Participants	56.2 Years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	25 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	54 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	69 Participants n=7 Participants	143 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	58 Participants n=5 Participants	56 Participants n=7 Participants	114 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	82 Participants n=5 Participants	79 Participants n=7 Participants	161 Participants n=5 Participants
Body Mass Index	36 kg/m^2 STANDARD_DEVIATION 9 • n=5 Participants	36 kg/m^2 STANDARD_DEVIATION 12 • n=7 Participants	36 kg/m^2 STANDARD_DEVIATION 11 • n=5 Participants
Home diabetes treatment No treatment	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Home diabetes treatment Oral diabetic agents	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Home diabetes treatment Insulin only	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Home diabetes treatment Insulin plus oral diabetic agent	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Home diabetes treatment Glucagon-like peptide-1 receptor agonists (GLP-1RA)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Mean Daily Blood Glucose Concentration in Hospitalized Patients Baseline	219.50 mg/dL Standard Deviation 50.21	218.19 mg/dL Standard Deviation 54.56
Mean Daily Blood Glucose Concentration in Hospitalized Patients Day 1 up to Day 10	179.75 mg/dL Standard Deviation 38.45	180.67 mg/dL Standard Deviation 45.10

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Degludec n=72 Participants 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.	Glargine n=59 Participants 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.
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	143.0 mg/dL Standard Deviation 42.5
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	133.8 mg/dL Standard Deviation 44.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=1378 Blood Glucose Point-of-Care Test 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.	Glargine n=1434 Blood Glucose Point-of-Care Test 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.
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	789 Blood Glucose Point-of-Care Test

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Number of Participants With an Episode of Hypoglycemia While Hospitalized	14 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized	52 Participants	47 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Daily Dose of Insulin in Hospitalized Patients Basal Insulin	30 International Units of insulin Standard Deviation 13	30 International Units of insulin Standard Deviation 18
Daily Dose of Insulin in Hospitalized Patients Prandial Insulin	11 International Units of insulin Standard Deviation 9	12 International Units of insulin Standard Deviation 11
Daily Dose of Insulin in Hospitalized Patients Total Daily Dose of Insulin	56 International Units of insulin Standard Deviation 24	60 International Units of insulin Standard Deviation 36

SECONDARY outcome

Timeframe: 4 and 12 weeks after hospital discharge

Population: This analysis includes participants completing the outpatient study visits.

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.

Outcome measures

Measure	Degludec n=72 Participants 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.	Glargine n=59 Participants 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.
Hemoglobin A1c (HbA1c) in Discharged Patients 12 weeks post-discharge	8.2 percent of RBCs with glycated hemoglobin Standard Deviation 1.9	7.4 percent of RBCs with glycated hemoglobin Standard Deviation 1.6
Hemoglobin A1c (HbA1c) in Discharged Patients 4 weeks post-discharge	8.3 percent of RBCs with glycated hemoglobin Standard Deviation 1.4	8.0 percent of RBCs with glycated hemoglobin Standard Deviation 1.4

SECONDARY outcome

Timeframe: Up to 12 weeks after hospital discharge

Population: This analysis includes participants completing the outpatient study visits.

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.

Outcome measures

Measure	Degludec n=72 Participants 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.	Glargine n=59 Participants 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.
Number of Hypoglycemia Episodes in Discharged Patients	16 episodes of hypoglycemia	19 episodes of hypoglycemia

SECONDARY outcome

Timeframe: Up to 12 weeks after hospital discharge

Population: This analysis includes participants completing the outpatient study visits.

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.

Outcome measures

Measure	Degludec n=72 Participants 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.	Glargine n=59 Participants 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.
Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients	1 episodes of significant hypoglycemia	1 episodes of significant hypoglycemia

SECONDARY outcome

Timeframe: Up to 12 weeks after hospital discharge

Population: This analysis includes participants completing the outpatient study visits.

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.

Outcome measures

Measure	Degludec n=72 Participants 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.	Glargine n=59 Participants 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.
Number of Episodes of Severe Hyperglycemia in Discharged Patients	211 episodes of severe hyperglycemia	55 episodes of severe hyperglycemia

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Number of Participants Experiencing Cardiac Complications During Hospitalization	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Number of Participants With Acute Kidney Injury During Hospitalization	5 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of hospital stay (an average of 10 days)

The length of hospital in days is presented here.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Length of Hospital Stay	6.7 days Interval 4.7 to 10.5	7.5 days Interval 4.7 to 11.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of hospital stay (an average of 10 days)

Hospital mortality is evaluated as the number of deaths among participants during hospitalization.

Outcome measures

Measure	Degludec n=82 Participants 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.	Glargine n=79 Participants 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.
Number of Participants Who Died During Hospitalization	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Degludec n=72 Participants 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.	Glargine n=59 Participants 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.
Number of Participants Experiencing Acute Kidney Injury in Discharged Patients	1 Participants	0 Participants

Adverse Events

Degludec

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Glargine

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Degludec n=82 participants at risk 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.	Glargine n=79 participants at risk 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.
Cardiac disorders Hospital readmission for chest pain	0.00% 0/82 • 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.	1.3% 1/79 • Number of events 1 • 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.
Renal and urinary disorders Hospital readmission for urinary tract infection	0.00% 0/82 • 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.	1.3% 1/79 • Number of events 1 • 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.
Nervous system disorders Hospital readmission for head injury	0.00% 0/82 • 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.	1.3% 1/79 • Number of events 1 • 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.
Infections and infestations Hospital readmisson for non-healing amputation stump	1.2% 1/82 • Number of events 1 • 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.	0.00% 0/79 • 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.
Cardiac disorders Hospital readmission for heart failure	1.2% 1/82 • Number of events 3 • 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.	0.00% 0/79 • 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.
Endocrine disorders Severe hypoglycemia	1.2% 1/82 • Number of events 1 • 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.	0.00% 0/79 • 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.

Other adverse events

Measure	Degludec n=82 participants at risk 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.	Glargine n=79 participants at risk 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.
Musculoskeletal and connective tissue disorders Emergency room visit for blunt chest trauma	0.00% 0/82 • 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.	1.3% 1/79 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Emergency room visit for bilateral knee pain	1.2% 1/82 • Number of events 1 • 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.	0.00% 0/79 • 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.
Infections and infestations Emergency room visit for wound infection	1.2% 1/82 • Number of events 1 • 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.	0.00% 0/79 • 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.
Eye disorders Emergency room visit for right eye medial stye	0.00% 0/82 • 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.	1.3% 1/79 • Number of events 1 • 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.
Cardiac disorders Emergency room visit for congestive heart failure	1.2% 1/82 • Number of events 1 • 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.	0.00% 0/79 • 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.
Cardiac disorders Emergency room visit for orthostatic hypotension	0.00% 0/82 • 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.	1.3% 1/79 • Number of events 1 • 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.

Additional Information

Dr. Guillermo E. Umpierrez

Emory University

Phone: (404) 778-1663

Email: geumpie@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place