Glargine U300 Hospital Trial

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03013985
• Collaborator: (none)
• Enrollment: 247
• Locations: 4
• Arms: 2
• Actual Duration (Months): 22.1
• Patients Per Site: 61.8
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Glargine U300; Drug: Glargine U100; Drug: Glulisine Insulin	Phase 4

Detailed Description

Several randomized clinical trials done previously in medicine and surgical patients with T2D have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in lower rate of hospital complications. Glargine U300 results in similar improvement but in lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and diabetes in the hospital setting. This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

Study Design

• Study Type: Interventional
• Actual Enrollment: 247 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes
• Actual Study Start Date: May 17, 2017
• Actual Primary Completion Date: Mar 22, 2019
• Actual Study Completion Date: Mar 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Basal bolus insulin with glargine U300 and glulisine insulin Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.	Drug: Glargine U300; Glargine U300 is a new generation long-acting insulin.; Other Names: Toujeo ; Drug: Glulisine Insulin; Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.; Other Names: Apidra
Active Comparator: Basal bolus insulin with glargine U100 and glulisine insulin Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.	Drug: Glargine U100; Glargine U100 is a long-acting insulin.; Other Names: Lantus ; Drug: Glulisine Insulin; Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.; Other Names: Apidra

Outcome Measures

Primary Outcome Measures

1. Mean Daily Blood Glucose Concentration Inpatient [up to 10 days (day of hospital discharge)]

   The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.

2. Mean Daily Blood Glucose Concentration After Hospital Discharge [assessed from day 11 (day after hospital discharge) up to 3 months]

   Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.

Secondary Outcome Measures

1. Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8% [up to 3 months post enrollment]

   Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.

2. Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8% [up to 3 months post enrollment]

   Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded

3. Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days [Up to 3 days]

   Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days

4. Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days [Up to 5 days]

   Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days

5. Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days [Up to 10 days]

   Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.

6. Percent of Blood Glucose 70-180 Measured by Point of Care Test [3 months post enrollment]

   Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test

7. Percent of Subjects With Hypoglycemic Events [3 months post enrollment]

   Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.

8. Percent of Subjects With Severe Hypoglycemia [3 months post enrollment]

   Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.

9. Number of Days of Hospital Stay [Up to 10 days]

   The number of days of hospital stay for each subject will be recorded.

10. Number Subjects With Cardiac Complications [3 months post enrollment]

    The number of subjects experiencing cardiac cardiac complications will be recorded.

11. Number of Patients With Acute Renal Failure [3 months post enrollment]

    The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine > 0.5 mg/dL from baseline).

12. Hospital Mortality [During hospital stay - up to 10 days]

    Number of hospital deaths that occur.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females between > 18 years admitted to a general medicine or surgical service.

• Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.

• Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).

Exclusion Criteria:

• Subjects with increased BG concentration, but without a known history of diabetes.

• Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).

• Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.

• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).

• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

• Female subjects who are pregnant or breast feeding at time of enrollment into the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
2	Emory University	Atlanta	Georgia	United States	30322
3	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
4	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Guillermo Umpierrez, MD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 28, 2019
• Informed Consent Form - Jan 28, 2019

More Information

Publications

None provided.

• Responsible Party: Guillermo Umpierrez, MD, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03013985
• Other Study ID Numbers: IRB00091740
• First Posted: Jan 9, 2017
• Last Update Posted: May 7, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guillermo Umpierrez, MD, Professor, Emory University: Blood glucose
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Insulin Glargine; Insulin glulisine

Study Results

Participant Flow

Pre-assignment Detail	Out of 247 consented, 9 were not randomized, 27 failed to start (19 did not receive study medication, 1 had eGFR out of range, 7 had admission BG >400 mg/dl)

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Period Title: Overall Study
STARTED	108	103
COMPLETED	92	84
NOT COMPLETED	16	19

Baseline Characteristics

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin	Total
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Total of all reporting groups
Overall Participants	108	103	211
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.2 (12.1)	56.3 (12.4)	56.7 (12.2)
Sex: Female, Male (Count of Participants)
Female	46 42.6%	39 37.9%	85 40.3%
Male	62 57.4%	64 62.1%	126 59.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 2.8%	4 3.9%	7 3.3%
Asian	1 0.9%	1 1%	2 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	68 63%	64 62.1%	132 62.6%
White	35 32.4%	34 33%	69 32.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.9%	0 0%	1 0.5%
Region of Enrollment (participants) [Number]
United States	108 100%	103 100%	211 100%

Outcome Measures

1. Primary Outcome

Title	Mean Daily Blood Glucose Concentration Inpatient
Description	The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.
Time Frame	up to 10 days (day of hospital discharge)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Mean (Standard Deviation) [mg/dL]	186 (40)	184 (46)

2. Primary Outcome

Title	Mean Daily Blood Glucose Concentration After Hospital Discharge
Description	Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.
Time Frame	assessed from day 11 (day after hospital discharge) up to 3 months

Outcome Measure Data

Analysis Population Description

The outpatient has less number of participants compared to the in-hospital part due to a1c less tan required for outpatient part, participants not wanting to continue in the discharge part and/or admission to long term facilities where we were not able to administer study medication.

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	41	45
Mean (Standard Deviation) [mg/dL]	171.6 (44.8)	164.5 (46.7)

3. Secondary Outcome

Title	Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%
Description	Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.
Time Frame	up to 3 months post enrollment

Outcome Measure Data

Analysis Population Description

subjects with HbA1c lower than 8% at admission

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	27	31
Mean (Standard Deviation) [mg/dL]	150 (14.4)	134.4 (19.3)

4. Secondary Outcome

Title	Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%
Description	Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded
Time Frame	up to 3 months post enrollment

Outcome Measure Data

Analysis Population Description

Patients with admission HbA1c higher than 8%

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	78	72
Mean (Standard Deviation) [mg/dL]	152.3 (38.5)	155.6 (36.5)

5. Secondary Outcome

Title	Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days
Description	Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days
Time Frame	Up to 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Mean (Standard Deviation) [mg/dL]	169.71 (42.35)	196.72 (56.60)

6. Secondary Outcome

Title	Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days
Description	Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days
Time Frame	Up to 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Mean (Standard Deviation) [mg/dL]	193.53 (43.1)	193.64 (42.6)

7. Secondary Outcome

Title	Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days
Description	Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.
Time Frame	Up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Mean (Standard Deviation) [mg/dL]	188.46 (34.7)	174.55 (34.1)

8. Secondary Outcome

Title	Percent of Blood Glucose 70-180 Measured by Point of Care Test
Description	Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test
Time Frame	3 months post enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Mean (Standard Deviation) [percentage of BG readings]	50.3 (27.5)	54.9 (29.3)

9. Secondary Outcome

Title	Percent of Subjects With Hypoglycemic Events
Description	Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.
Time Frame	3 months post enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Number [percentage of subjects]	8.7	9.5

10. Secondary Outcome

Title	Percent of Subjects With Severe Hypoglycemia
Description	Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.
Time Frame	3 months post enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Number [percentage of subjects]	0	6

11. Secondary Outcome

Title	Number of Days of Hospital Stay
Description	The number of days of hospital stay for each subject will be recorded.
Time Frame	Up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Median (Inter-Quartile Range) [days]	6	4

12. Secondary Outcome

Title	Number Subjects With Cardiac Complications
Description	The number of subjects experiencing cardiac cardiac complications will be recorded.
Time Frame	3 months post enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Count of Participants [Participants]	5 4.6%	11 10.7%

13. Secondary Outcome

Title	Number of Patients With Acute Renal Failure
Description	The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine > 0.5 mg/dL from baseline).
Time Frame	3 months post enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Count of Participants [Participants]	1 0.9%	1 1%

14. Secondary Outcome

Title	Hospital Mortality
Description	Number of hospital deaths that occur.
Time Frame	During hospital stay - up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Measure Participants	92	84
Number [events]	0	2

Adverse Events

Time Frame	3 months.
Arm/Group Title	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin		Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
Arm/Group Description	Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.		Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
All Cause Mortality
	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin		Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		2/103 (1.9%)
Serious Adverse Events
	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin		Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/108 (19.4%)		21/103 (20.4%)
Cardiac disorders
Arrhythmia	1/108 (0.9%)	1	3/103 (2.9%)	3
Chronic Heart Failure	4/108 (3.7%)	6	8/103 (7.8%)	10
Syncope	1/108 (0.9%)	1	0/103 (0%)	0
Gastrointestinal disorders
Gastroentestinal disorder	4/108 (3.7%)	6	0/103 (0%)	0
General disorders
Infection	3/108 (2.8%)	4	4/103 (3.9%)	4
Surgery	2/108 (1.9%)	2	0/103 (0%)	0
ICU admission	1/108 (0.9%)	1	0/103 (0%)	0
Immune system disorders
Skin graft failure	0/108 (0%)	0	1/103 (1%)	1
Metabolism and nutrition disorders
Hyperglycemia	1/108 (0.9%)	1	1/103 (1%)	1
Nervous system disorders
Tremor	1/108 (0.9%)	1	0/103 (0%)	0
Numbness on right side of body	0/108 (0%)	0	1/103 (1%)	1
Renal and urinary disorders
Acute Kidney Injury	1/108 (0.9%)	1	1/103 (1%)	1
Respiratory, thoracic and mediastinal disorders
Hypoxia	0/108 (0%)	0	1/103 (1%)	1
Surgical and medical procedures
Malfunctioning Peripherally Inserted Central Catheter	1/108 (0.9%)	1	1/103 (1%)	1
Vascular disorders
Stroke	1/108 (0.9%)	1	0/103 (0%)	0
Other (Not Including Serious) Adverse Events
	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin		Basal Bolus Insulin With Glargine U100 and Glulisine Insulin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/108 (9.3%)		18/103 (17.5%)
Cardiac disorders
Chronic heart failure	0/108 (0%)	0	1/103 (1%)	1
Ear and labyrinth disorders
Cerumen Impaction	0/108 (0%)	0	1/103 (1%)	1
Endocrine disorders
Hyperglycemia	0/108 (0%)	0	2/103 (1.9%)	2
Gastrointestinal disorders
Gastroparesis	1/108 (0.9%)	2	0/103 (0%)	0
General disorders
Infection	0/108 (0%)	0	3/103 (2.9%)	3
Leg Swelling	0/108 (0%)	0	2/103 (1.9%)	3
Pain	1/108 (0.9%)	1	2/103 (1.9%)	3
Trauma	4/108 (3.7%)	4	1/103 (1%)	1
Tremors	1/108 (0.9%)	1	0/103 (0%)	0
Metabolism and nutrition disorders
Hyperkalemia	0/108 (0%)	0	1/103 (1%)	1
Psychiatric disorders
Polysubstance abuse	1/108 (0.9%)	1	0/103 (0%)	0
Reproductive system and breast disorders
Scrotal Bleeding	0/108 (0%)	0	1/103 (1%)	1
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation	0/108 (0%)	0	1/103 (1%)	1
Cough	1/108 (0.9%)	1	0/103 (0%)	0
Social circumstances
Social (homelessness)	0/108 (0%)	0	1/103 (1%)	1
Surgical and medical procedures
Skin Graft revision	0/108 (0%)	0	1/103 (1%)	1
Wound Check	1/108 (0.9%)	1	1/103 (1%)	1

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.