Trial Outcomes & Findings for Glargine U300 Hospital Trial (NCT NCT03013985)

NCT ID: NCT03013985

Last Updated: 2020-05-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 247 participants
• Primary outcome timeframe: up to 10 days (day of hospital discharge)
• Results posted on: 2020-05-07

Participant Flow

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)

Participant milestones

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

Reasons for withdrawal

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U300: Glargine U300 is a new generation long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. Glargine U100: Glargine U100 is a long-acting insulin. Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	14	17

Baseline Characteristics

Glargine U300 Hospital Trial

Baseline characteristics by cohort

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=108 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=103 Participants 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 n=211 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 12.1 • n=5 Participants	56.3 years STANDARD_DEVIATION 12.4 • n=7 Participants	56.7 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	39 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	64 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	68 Participants n=5 Participants	64 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	108 participants n=5 Participants	103 participants n=7 Participants	211 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Mean Daily Blood Glucose Concentration Inpatient	186 mg/dL Standard Deviation 40	184 mg/dL Standard Deviation 46

PRIMARY outcome

Timeframe: assessed from day 11 (day after hospital discharge) up to 3 months

Population: 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.

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.

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=41 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=45 Participants 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.
Mean Daily Blood Glucose Concentration After Hospital Discharge	171.6 mg/dL Standard Deviation 44.8	164.5 mg/dL Standard Deviation 46.7

SECONDARY outcome

Timeframe: up to 3 months post enrollment

Population: subjects with HbA1c lower than 8% at admission

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.

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=27 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=31 Participants 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.
Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%	150 mg/dL Standard Deviation 14.4	134.4 mg/dL Standard Deviation 19.3

SECONDARY outcome

Timeframe: up to 3 months post enrollment

Population: Patients with admission HbA1c higher than 8%

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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=78 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=72 Participants 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.
Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%	152.3 mg/dL Standard Deviation 38.5	155.6 mg/dL Standard Deviation 36.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days	169.71 mg/dL Standard Deviation 42.35	196.72 mg/dL Standard Deviation 56.60

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days	193.53 mg/dL Standard Deviation 43.1	193.64 mg/dL Standard Deviation 42.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days	188.46 mg/dL Standard Deviation 34.7	174.55 mg/dL Standard Deviation 34.1

SECONDARY outcome

Timeframe: 3 months post enrollment

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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Percent of Blood Glucose 70-180 Measured by Point of Care Test	50.3 percentage of BG readings Standard Deviation 27.5	54.9 percentage of BG readings Standard Deviation 29.3

SECONDARY outcome

Timeframe: 3 months post enrollment

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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Percent of Subjects With Hypoglycemic Events	8.7 percentage of subjects	9.5 percentage of subjects

SECONDARY outcome

Timeframe: 3 months post enrollment

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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Percent of Subjects With Severe Hypoglycemia	0 percentage of subjects	6 percentage of subjects

SECONDARY outcome

Timeframe: Up to 10 days

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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Number of Days of Hospital Stay	6 days Interval 4.0 to 8.0	4 days Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 3 months post enrollment

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

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Number Subjects With Cardiac Complications	5 Participants	11 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Number of Patients With Acute Renal Failure	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During hospital stay - up to 10 days

Number of hospital deaths that occur.

Outcome measures

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=92 Participants 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=84 Participants 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.
Hospital Mortality	0 events	2 events

Adverse Events

Basal Bolus Insulin With Glargine U300 and Glulisine Insulin

Serious events: 21 serious events

Other events: 10 other events

Deaths: 0 deaths

Basal Bolus Insulin With Glargine U100 and Glulisine Insulin

Serious events: 21 serious events

Other events: 18 other events

Deaths: 2 deaths

Serious adverse events

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=108 participants at risk 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=103 participants at risk 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.
Renal and urinary disorders Acute Kidney Injury	0.93% 1/108 • Number of events 1 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Cardiac disorders Arrhythmia	0.93% 1/108 • Number of events 1 • 3 months.	2.9% 3/103 • Number of events 3 • 3 months.
Gastrointestinal disorders Gastroentestinal disorder	3.7% 4/108 • Number of events 6 • 3 months.	0.00% 0/103 • 3 months.
Metabolism and nutrition disorders Hyperglycemia	0.93% 1/108 • Number of events 1 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Cardiac disorders Chronic Heart Failure	3.7% 4/108 • Number of events 6 • 3 months.	7.8% 8/103 • Number of events 10 • 3 months.
General disorders Infection	2.8% 3/108 • Number of events 4 • 3 months.	3.9% 4/103 • Number of events 4 • 3 months.
General disorders Surgery	1.9% 2/108 • Number of events 2 • 3 months.	0.00% 0/103 • 3 months.
Vascular disorders Stroke	0.93% 1/108 • Number of events 1 • 3 months.	0.00% 0/103 • 3 months.
Nervous system disorders Tremor	0.93% 1/108 • Number of events 1 • 3 months.	0.00% 0/103 • 3 months.
Surgical and medical procedures Malfunctioning Peripherally Inserted Central Catheter	0.93% 1/108 • Number of events 1 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Cardiac disorders Syncope	0.93% 1/108 • Number of events 1 • 3 months.	0.00% 0/103 • 3 months.
Immune system disorders Skin graft failure	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Nervous system disorders Numbness on right side of body	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
General disorders ICU admission	0.93% 1/108 • Number of events 1 • 3 months.	0.00% 0/103 • 3 months.

Other adverse events

Measure	Basal Bolus Insulin With Glargine U300 and Glulisine Insulin n=108 participants at risk 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.	Basal Bolus Insulin With Glargine U100 and Glulisine Insulin n=103 participants at risk 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.
Gastrointestinal disorders Gastroparesis	0.93% 1/108 • Number of events 2 • 3 months.	0.00% 0/103 • 3 months.
Endocrine disorders Hyperglycemia	0.00% 0/108 • 3 months.	1.9% 2/103 • Number of events 2 • 3 months.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
General disorders Infection	0.00% 0/108 • 3 months.	2.9% 3/103 • Number of events 3 • 3 months.
General disorders Leg Swelling	0.00% 0/108 • 3 months.	1.9% 2/103 • Number of events 3 • 3 months.
General disorders Pain	0.93% 1/108 • Number of events 1 • 3 months.	1.9% 2/103 • Number of events 3 • 3 months.
Psychiatric disorders Polysubstance abuse	0.93% 1/108 • Number of events 1 • 3 months.	0.00% 0/103 • 3 months.
Surgical and medical procedures Skin Graft revision	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Reproductive system and breast disorders Scrotal Bleeding	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Social circumstances Social (homelessness)	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
General disorders Trauma	3.7% 4/108 • Number of events 4 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
General disorders Tremors	0.93% 1/108 • Number of events 1 • 3 months.	0.00% 0/103 • 3 months.
Surgical and medical procedures Wound Check	0.93% 1/108 • Number of events 1 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Ear and labyrinth disorders Cerumen Impaction	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Cardiac disorders Chronic heart failure	0.00% 0/108 • 3 months.	0.97% 1/103 • Number of events 1 • 3 months.
Respiratory, thoracic and mediastinal disorders Cough	0.93% 1/108 • Number of events 1 • 3 months.	0.00% 0/103 • 3 months.

Additional Information

Dr. Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: GEUMPIE@emory.edu

Results disclosure agreements

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