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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03336528
• Collaborator: Novo Nordisk A/S (Industry)
• Enrollment: 180
• Locations: 4
• Arms: 2
• Actual Duration (Months): 37.9
• Patients Per Site: 45
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Degludec; Drug: Glargine; Drug: Aspart	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial Comparing Insulin Degludec and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes
• Actual Study Start Date: Jan 2, 2018
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Degludec inpatient Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.	Drug: Degludec; 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.; Other Names: Tresiba ; Drug: Aspart; 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.; Other Names: Novolog
Active Comparator: Glargine U100 inpatient Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.	Drug: Glargine; 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.; Other Names: Lantus ; Drug: Aspart; 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.; Other Names: Novolog

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

Other Outcome Measures

1. 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.

2. 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.

3. Length of Hospital Stay [Duration of hospital stay (an average of 10 days)]

   The length of hospital in days is presented here.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Hospital	Atlanta	Georgia	United States	30308
2	Emory University Hospital Clinical Research Network	Atlanta	Georgia	United States	30322
3	Mount Sinai	New York	New York	United States	10029
4	Providence Medical Research Centre	Spokane	Washington	United States	99204

Sponsors and Collaborators

• Emory University
• Novo Nordisk A/S

Investigators

• Principal Investigator: Guillermo Umpierrez, MD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 17, 2020

More Information

Publications

None provided.

• Responsible Party: Guillermo Umpierrez, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03336528
• Other Study ID Numbers: IRB00087816
• First Posted: Nov 8, 2017
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Guillermo Umpierrez, Professor, Emory University: Long-acting insulin analog
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Glargine; Insulin Aspart

Study Results

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.

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	92	88
Participated in Optional Outpatient Study	72	59
COMPLETED	82	79
NOT COMPLETED	10	9

Baseline Characteristics

Arm/Group Title	Degludec	Glargine	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	82	79	161
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	55.6 (12)	56.7 (10)	56.2 (11)
Sex: Female, Male (Count of Participants)
Female	35 42.7%	25 31.6%	60 37.3%
Male	47 57.3%	54 68.4%	101 62.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 9.8%	10 12.7%	18 11.2%
Not Hispanic or Latino	74 90.2%	69 87.3%	143 88.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	1 1.2%	0 0%	1 0.6%
Black or African American	58 70.7%	56 70.9%	114 70.8%
White	16 19.5%	18 22.8%	34 21.1%
More than one race	7 8.5%	5 6.3%	12 7.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	82 100%	79 100%	161 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	36 (9)	36 (12)	36 (11)
Home diabetes treatment (Count of Participants)
No treatment	7 8.5%	10 12.7%	17 10.6%
Oral diabetic agents	18 22%	15 19%	33 20.5%
Insulin only	30 36.6%	32 40.5%	62 38.5%
Insulin plus oral diabetic agent	27 32.9%	21 26.6%	48 29.8%
Glucagon-like peptide-1 receptor agonists (GLP-1RA)	0 0%	1 1.3%	1 0.6%

Outcome Measures

1. Primary Outcome

Title	Mean Daily Blood Glucose Concentration in Hospitalized Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Baseline	219.50 (50.21)	218.19 (54.56)
Day 1 up to Day 10	179.75 (38.45)	180.67 (45.10)

2. Primary Outcome

Title	Mean Daily Blood Glucose Concentration in Discharged Patients.
Description	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

Outcome Measure Data

Analysis Population Description

This analysis includes participants completing the outpatient study visits.

Arm/Group Title	Degludec During Hospitalization	Glargine During Hospitalization
Arm/Group Description	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.	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.
Measure Participants	72	59
Day after discharge up to the 4 week post-discharge study visit	157.0 (46.4)	143.0 (42.5)
4 week post-discharge up to the 12 week post-discharge study visit	148.7 (43.6)	133.8 (44.2)

3. Secondary Outcome

Title	Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Measure Blood Glucose Point-of-Care Test	1378	1434
Count of Units [Blood Glucose Point-of-Care Test]	758	789

4. Secondary Outcome

Title	Number of Participants With an Episode of Hypoglycemia While Hospitalized
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Count of Participants [Participants]	14 17.1%	15 19%

5. Secondary Outcome

Title	Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Count of Participants [Participants]	3 3.7%	1 1.3%

6. Secondary Outcome

Title	Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Count of Participants [Participants]	52 63.4%	47 59.5%

8. Secondary Outcome

Title	Daily Dose of Insulin in Hospitalized Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Basal Insulin	30 (13)	30 (18)
Prandial Insulin	11 (9)	12 (11)
Total Daily Dose of Insulin	56 (24)	60 (36)

9. Secondary Outcome

Title	Hemoglobin A1c (HbA1c) in Discharged Patients
Description	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

Outcome Measure Data

Analysis Population Description

This analysis includes participants completing the outpatient study visits.

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	72	59
4 weeks post-discharge	8.3 (1.4)	8.0 (1.4)
12 weeks post-discharge	8.2 (1.9)	7.4 (1.6)

10. Secondary Outcome

Title	Number of Hypoglycemia Episodes in Discharged Patients
Description	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

Outcome Measure Data

Analysis Population Description

This analysis includes participants completing the outpatient study visits.

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	72	59
Number [episodes of hypoglycemia]	16	19

11. Secondary Outcome

Title	Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients
Description	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

Outcome Measure Data

Analysis Population Description

This analysis includes participants completing the outpatient study visits.

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	72	59
Number [episodes of significant hypoglycemia]	1	1

12. Secondary Outcome

Title	Number of Episodes of Severe Hyperglycemia in Discharged Patients
Description	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

Outcome Measure Data

Analysis Population Description

This analysis includes participants completing the outpatient study visits.

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	72	59
Number [episodes of severe hyperglycemia]	211	55

13. Other Pre-specified Outcome

Title	Number of Participants Experiencing Cardiac Complications During Hospitalization
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Count of Participants [Participants]	0 0%	0 0%

14. Other Pre-specified Outcome

Title	Number of Participants With Acute Kidney Injury During Hospitalization
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Count of Participants [Participants]	5 6.1%	10 12.7%

15. Other Pre-specified Outcome

Title	Length of Hospital Stay
Description	The length of hospital in days is presented here.
Time Frame	Duration of hospital stay (an average of 10 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Median (Inter-Quartile Range) [days]	6.7	7.5

16. Other Pre-specified Outcome

Title	Number of Participants Who Died During Hospitalization
Description	Hospital mortality is evaluated as the number of deaths among participants during hospitalization.
Time Frame	Duration of hospital stay (an average of 10 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	82	79
Count of Participants [Participants]	0 0%	1 1.3%

17. Other Pre-specified Outcome

Title	Number of Participants Experiencing Acute Kidney Injury in Discharged Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degludec	Glargine
Arm/Group Description	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.	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.
Measure Participants	72	59
Count of Participants [Participants]	1 1.2%	0 0%

Adverse Events

Time Frame	Information on adverse events was collected from the time of consent during hospitalization for up to 3 months after hospital discharge.
Adverse Event Reporting Description	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.
Arm/Group Title	Degludec		Glargine
Arm/Group Description	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.		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.
All Cause Mortality
	Degludec		Glargine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/82 (1.2%)		1/79 (1.3%)
Serious Adverse Events
	Degludec		Glargine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/82 (3.7%)		3/79 (3.8%)
Cardiac disorders
Hospital readmission for chest pain	0/82 (0%)	0	1/79 (1.3%)	1
Hospital readmission for heart failure	1/82 (1.2%)	3	0/79 (0%)	0
Endocrine disorders
Severe hypoglycemia	1/82 (1.2%)	1	0/79 (0%)	0
Infections and infestations
Hospital readmisson for non-healing amputation stump	1/82 (1.2%)	1	0/79 (0%)	0
Nervous system disorders
Hospital readmission for head injury	0/82 (0%)	0	1/79 (1.3%)	1
Renal and urinary disorders
Hospital readmission for urinary tract infection	0/82 (0%)	0	1/79 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Degludec		Glargine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/82 (3.7%)		3/79 (3.8%)
Cardiac disorders
Emergency room visit for congestive heart failure	1/82 (1.2%)	1	0/79 (0%)	0
Emergency room visit for orthostatic hypotension	0/82 (0%)	0	1/79 (1.3%)	1
Eye disorders
Emergency room visit for right eye medial stye	0/82 (0%)	0	1/79 (1.3%)	1
Infections and infestations
Emergency room visit for wound infection	1/82 (1.2%)	1	0/79 (0%)	0
Musculoskeletal and connective tissue disorders
Emergency room visit for blunt chest trauma	0/82 (0%)	0	1/79 (1.3%)	1
Emergency room visit for bilateral knee pain	1/82 (1.2%)	1	0/79 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.