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

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Hyperglycemia
Interventions	Drug: Human regular insulin; Drug: Insulin lispro; Drug: Insulin glargine
Enrollment	16

Participant Flow

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Recruitment Details
Pre-assignment Details

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
Reason Not Completed
Lost to Follow-up	0	2
Protocol Violation	2	1
Death	1	0

Baseline Characteristics

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

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 Number of Baseline Participants		9	7	16
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	9 participants	7 participants	16 participants
		60.2 (16.8)	51.4 (8.5)	56.4 (14.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	7 participants	16 participants
	Female	5 55.6%	2 28.6%	7 43.8%
	Male	4 44.4%	5 71.4%	9 56.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	7 participants	16 participants
	Hispanic or Latino	1 11.1%	0 0.0%	1 6.3%
	Not Hispanic or Latino	8 88.9%	7 100.0%	15 93.8%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	7 participants	16 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	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%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	9 participants	7 participants	16 participants
		9	7	16

Outcome Measures

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

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).
Overall Number of Participants Analyzed	9	6
Mean (Standard Deviation); Unit of Measure: 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).
Overall Number of Participants Analyzed	9	6
Overall Number of Units Analyzed; Type of Units Analyzed: Capillary plasma glucose measurements	70	51
Measure Type: Number; Unit of Measure: 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).
Overall Number of Participants Analyzed	9	6
Mean (Standard Deviation); Unit of Measure: mg/dL
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 [1] (NA)
Day 5 (n=1, n=1)	154.8 [1] (NA)	104.6 [1] (NA)
Day 6 (n=1, n=1)	138.0 [1] (NA)	111.0 [1] (NA)
Day 7 (n=0, n=1)	NA [2] (NA)	108.0 [1] (NA)

[1]

Standard Deviation cannot be calculated when there is only one participant.

[2]

Cannot calculate a Mean or Standard Deviation with zero participants.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	9	6
Measure Type: Number; Unit of Measure: hypoglycemic episodes
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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	9	7
Measure Type: Number; Unit of Measure: participants
	1	2

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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).
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
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 (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Sliding Scale Regular Insulin		Basal-bolus Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.11%)		0/7 (0.00%)
Cardiac disorders
Myocardial infarction † 1	1/9 (11.11%)	1	0/7 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 15.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Sliding Scale Regular Insulin		Basal-bolus Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.11%)		2/7 (28.57%)
Gastrointestinal disorders
Constipation † 1	1/9 (11.11%)	1	1/7 (14.29%)	1
Investigations
High density lipoprotein decreased † 1	0/9 (0.00%)	0	1/7 (14.29%)	1
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 15.0

Limitations and Caveats

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

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

Go to 

Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: Chief Medical Officer

Organization: Eli Lilly and Company

Phone: 800-545-5979

Publications:

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.

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, 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.

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.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01136746 History of Changes
Other Study ID Numbers:	13698; F3Z-US-IOPZ ( Other Identifier: Eli Lilly and Company )
First Submitted:	June 2, 2010
First Posted:	June 3, 2010
Results First Submitted:	September 12, 2012
Results First Posted:	October 12, 2012
Last Update Posted:	November 13, 2012