HMH: Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01136746
• Collaborator: (none)
• Enrollment: 16
• Locations: 12
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.

Condition or Disease	Intervention/Treatment	Phase
Hyperglycemia	Drug: Human regular insulin; Drug: Insulin lispro; Drug: Insulin glargine	Phase 3

Detailed Description

This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients. In this study, basal-bolus therapy will consist of once-daily glargine plus lispro 3 to 4 times daily adjusted to achieve pre-meal capillary plasma glucose <140 milligrams per deciliter (mg/dL) and bedtime capillary plasma glucose <180 mg/dL for patients who are eating [predose plasma glucose <140 mg/dL for patients with nil per os (NPO) orders]; sliding scale insulin will be administered using human regular insulin 4 times daily as needed adjusted to achieve predose capillary plasma glucose target <140 mg/dL in patients who are eating or have NPO orders.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial of Subcutaneous Analog Basal Bolus Therapy Versus Sliding Scale Human Regular Insulin in the Hospital Management of Hyperglycemia in Non-Critically Ill Patients Without Known History of Diabetes: The HMH Trial
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sliding scale regular insulin	Drug: Human regular insulin; Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization); Other Names: Humulin R LY041001
Experimental: Basal-bolus therapy	Drug: Insulin lispro; Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization); Other Names: Humalog LY275585 ; Drug: Insulin glargine; Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization); Other Names: Lantus

Outcome Measures

Primary Outcome Measures

1. Mean Plasma Glucose (MPG) Throughout Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

   Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.

2. Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

   Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.

Secondary Outcome Measures

1. Mean Plasma Glucose (MPG) by Hospital Day [Day 1 up to day 7 of hospital study period]

   The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7.

2. Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day [Day 1 up to day 10 of hospital study period]

   Due to low enrollment, this outcome measure was not analyzed.

3. Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

   Due to low enrollment, this outcome measure was not analyzed.

4. Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day [Day 1 up to day 10 of hospital study period]

   Due to low enrollment, this outcome measure was not analyzed.

5. Mean Fasting Plasma Glucose (FPG) by Hospital Day [Day 1 up to day 10 of hospital study period]

   Due to low enrollment, this outcome measure was not analyzed.

6. Mean FPG Throughout Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

   Due to low enrollment, this outcome measure was not analyzed.

7. Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period [Throughout the hospital study period (1 to 10 days post-randomization)]

   Due to low enrollment, this outcome measure was not analyzed.

8. Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day [Day 1 up to day 10 of hospital study period]

   Due to low enrollment, this outcome measure was not analyzed.

9. Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period [Throughout the hospital study period (1 to 10 days post-randomization)]

   Due to low enrollment, this outcome measure was not analyzed.

10. Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day [Day 1 up to day 10 of hospital study period]

    Due to low enrollment, this outcome measure was not analyzed.

11. Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period [Throughout the hospital study period (1 to 10 days post-randomization)]

    Due to low enrollment, this outcome measure was not analyzed.

12. Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day [Day 1 up to day 10 of hospital study period]

    Due to low enrollment, this outcome measure was not analyzed.

13. Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period [Throughout the hospital study period (1 to 10 days post-randomization)]

    Due to low enrollment, this outcome measure was not analyzed.

14. TDD of Insulin (Units/kg) Throughout the Hospital Study Period [Throughout the hospital study period (1 to 10 days post-randomization)]

    Due to low enrollment, this outcome measure was not analyzed.

15. TDD of Insulin (Units) by Hospital Day [Day 1 up to day 10 of hospital study period]

    Due to low enrollment, this outcome measure was not analyzed.

16. TDD of Insulin (Units/kg) by Hospital Day [Day 1 up to day 10 of hospital study period]

    Due to low enrollment, this outcome measure was not analyzed.

17. Length of Hospital Stay Post-randomization Throughout the Hospital Study Period [Throughout the hospital study period (1 to 10 days post-randomization)]

    Due to low enrollment, this outcome measure was not analyzed.

18. Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

    Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.

19. Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

    Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.

20. Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day [Day 1 up to day 10 of hospital study period]

    Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.

21. Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day [Day 1 up to day 10 of hospital study period]

    Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.

22. Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

    Treatment-emergent adverse event - any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.

23. Percentage of Participants Requiring Intensive Care Unit Transfer [Throughout hospital study period (1 to 10 days post-randomization)]

    Due to low enrollment, this outcome measure was not analyzed.

24. Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period [Throughout hospital study period (1 to 10 days post-randomization)]

    Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.

25. Percentage of Participants With Documented Nosocomial Infections [Throughout hospital study period (1 to 10 days post-randomization)]

    Due to low enrollment, this outcome measure was not analyzed.

26. Number of Participants With Major Adverse Cardiovascular Events (MACE) [Throughout hospital study period (1 to 10 days post-randomization)]

    MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.

Eligibility Criteria

Criteria

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

Major Inclusion Criteria:

• No known history of diabetes

• Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL

• Non-critically ill and admitted to acute care medical services

• Have a body mass index greater than or equal to 18.5 kg/m^{2 and less than or equal to 45 kilograms per square meter (kg/m}2)

Major Exclusion Criteria:

• Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization

• Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL

• Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry

• Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period

• Expected hospitalization less than 24 hours post-randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Birmingham	Alabama	United States	35294
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Jacksonville	Florida	United States	32209
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Miami	Florida	United States	33136
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Weston	Florida	United States	33331
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Atlanta	Georgia	United States	30312
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Topeka	Kansas	United States	66604
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hazard	Kentucky	United States	41701
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bangor	Maine	United States	04401
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kansas City	Missouri	United States	64111
10	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cleveland	Ohio	United States	44106
11	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Charleston	South Carolina	United States	29425
12	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Memphis	Tennessee	United States	38104

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

• American Diabetes Association. Standards of medical care in diabetes--2010. Diabetes Care. 2010 Jan;33 Suppl 1:S11-61. doi: 10.2337/dc10-S011. Erratum in: Diabetes Care. 2010 Mar;33(3):692.
• Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Endocr Pract. 2009 May-Jun;15(4):353-69. doi: 10.4158/EP09102.RA.
• Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.
• Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. Epub 2007 May 18.
• Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. Review.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01136746
• Other Study ID Numbers: 13698; F3Z-US-IOPZ
• First Posted: Jun 3, 2010
• Last Update Posted: Nov 13, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Eli Lilly and Company: Hyperglycemia; Diabetes; Hospital; Diabetic
• Additional relevant MeSH terms: Hyperglycemia; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro

Study Results

Participant Flow

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Period Title: Overall Study
STARTED	9	7
COMPLETED	6	4
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy	Total
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).	Total of all reporting groups
Overall Participants	9	7	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.2 (16.8)	51.4 (8.5)	56.4 (14.1)
Sex: Female, Male (Count of Participants)
Female	5 55.6%	2 28.6%	7 43.8%
Male	4 44.4%	5 71.4%	9 56.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 11.1%	0 0%	1 6.3%
Not Hispanic or Latino	8 88.9%	7 100%	15 93.8%
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	0 0%	0 0%	0 0%
Black or African American	5 55.6%	2 28.6%	7 43.8%
White	4 44.4%	5 71.4%	9 56.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	7 100%	16 100%

Outcome Measures

1. Primary Outcome

Title	Mean Plasma Glucose (MPG) Throughout Hospital Study Period
Description	Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

All randomized participants who had at least one post-baseline glucose measurement.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	9	6
Mean (Standard Deviation) [milligrams per deciliter (mg/dL)]	167.6 (48.5)	128.4 (22.4)

2. Primary Outcome

Title	Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period
Description	Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

All randomized participants who had at least one post-baseline glucose measurement.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	9	6
Measure capillary plasma glucose measurements	70	51
Number [percentage of capillary PG measurements]	81.4	84.3

3. Secondary Outcome

Title	Mean Plasma Glucose (MPG) by Hospital Day
Description	The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7.
Time Frame	Day 1 up to day 7 of hospital study period

Outcome Measure Data

Analysis Population Description

All randomized participants who had at least one post-baseline glucose measurement and a plasma glucose measurement at specified timepoint.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	9	6
Day 1 (n=6, n=6)	178.1 (54.9)	149.9 (17.2)
Day 2 (n=8, n=5)	175.2 (57.9)	124.0 (29.8)
Day 3 (n=6, n=3)	151.0 (46.9)	128.5 (28.5)
Day 4 (n=2, n=1)	132.5 (2.12)	96.3 (NA)
Day 5 (n=1, n=1)	154.8 (NA)	104.6 (NA)
Day 6 (n=1, n=1)	138.0 (NA)	111.0 (NA)
Day 7 (n=0, n=1)	NA (NA)	108.0 (NA)

4. Secondary Outcome

Title	Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

5. Secondary Outcome

Title	Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

6. Secondary Outcome

Title	Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

7. Secondary Outcome

Title	Mean Fasting Plasma Glucose (FPG) by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

8. Secondary Outcome

Title	Mean FPG Throughout Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

9. Secondary Outcome

Title	Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout the hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

10. Secondary Outcome

Title	Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

11. Secondary Outcome

Title	Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout the hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

12. Secondary Outcome

Title	Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

13. Secondary Outcome

Title	Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout the hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

14. Secondary Outcome

Title	Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

15. Secondary Outcome

Title	Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout the hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

16. Secondary Outcome

Title	TDD of Insulin (Units/kg) Throughout the Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout the hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

17. Secondary Outcome

Title	TDD of Insulin (Units) by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

18. Secondary Outcome

Title	TDD of Insulin (Units/kg) by Hospital Day
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

19. Secondary Outcome

Title	Length of Hospital Stay Post-randomization Throughout the Hospital Study Period
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout the hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

20. Secondary Outcome

Title	Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period
Description	Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

All randomized participants who had at least one post-baseline glucose measurement.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	9	6
Hypoglycemic Episodes	1	3
Severe Hypoglycemic Episodes	0	0

21. Secondary Outcome

Title	Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period
Description	Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

22. Secondary Outcome

Title	Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day
Description	Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

23. Secondary Outcome

Title	Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day
Description	Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Day 1 up to day 10 of hospital study period

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

24. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period
Description	Treatment-emergent adverse event - any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	9	7
Number [participants]	1 11.1%	2 28.6%

25. Secondary Outcome

Title	Percentage of Participants Requiring Intensive Care Unit Transfer
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

26. Secondary Outcome

Title	Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period
Description	Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

27. Secondary Outcome

Title	Percentage of Participants With Documented Nosocomial Infections
Description	Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

28. Secondary Outcome

Title	Number of Participants With Major Adverse Cardiovascular Events (MACE)
Description	MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.
Time Frame	Throughout hospital study period (1 to 10 days post-randomization)

Outcome Measure Data

Analysis Population Description

Due to low enrollment, zero participants were analyzed.

Arm/Group Title	Sliding Scale Regular Insulin	Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
Measure Participants	0	0

Adverse Events

Arm/Group Title	Sliding Scale Regular Insulin		Basal-bolus Therapy
Arm/Group Description	Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).		Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization). Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).
All Cause Mortality
	Sliding Scale Regular Insulin		Basal-bolus Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sliding Scale Regular Insulin		Basal-bolus Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		0/7 (0%)
Cardiac disorders
Myocardial infarction	1/9 (11.1%)	1	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Sliding Scale Regular Insulin		Basal-bolus Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		2/7 (28.6%)
Gastrointestinal disorders
Constipation	1/9 (11.1%)	1	1/7 (14.3%)	1
Investigations
High density lipoprotein decreased	0/9 (0%)	0	1/7 (14.3%)	1

Limitations/Caveats

Due to low enrollment, this trial was terminated early, leading to small numbers of participants analyzed or some outcome measures not being able to be analyzed at all.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.