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

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ClinicalTrials.gov Identifier: NCT01136746
Recruitment Status : Terminated (Low enrollment)
First Posted : June 3, 2010
Results First Posted : October 12, 2012
Last Update Posted : November 13, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy Total
Hide 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
Hide 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
1.Primary Outcome
Title Mean Plasma Glucose (MPG) Throughout Hospital Study Period
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout the hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout the hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout the hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout the hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout the hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Day 1 up to day 10 of hospital study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout the hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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
Hide Description Due to low enrollment, this outcome measure was not analyzed.
Time Frame Throughout hospital study period (1 to 10 days post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, zero participants were analyzed.
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sliding Scale Regular Insulin Basal-bolus Therapy
Hide 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   --/--      --/--    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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.
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
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