Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin (HMH)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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
Interventional
Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Hyperglycemia
Drug: Human regular insulin
Drug: Insulin lispro
Drug: Insulin glargine
16
Go to
Recruitment Details
Pre-assignment Details
Arm/Group Title
Sliding Scale Regular Insulin
Basal-bolus Therapy
Arm/Group Description
Human regular insulin: Administered...
Insulin lispro: Administered subcut...
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
Go to
Arm/Group Title
Sliding Scale Regular Insulin
Basal-bolus Therapy
Total
Arm/Group Description
Human regular insulin: Administered...
Insulin lispro: Administered subcut...
Total of all reporting groups
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]
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
Go to
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 fro...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 pl...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 AnalyzedType of Units Analyzed: Capillary plasma glucose measurements
70
51
Measure Type: NumberUnit 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 enr...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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
(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)
Standard Deviation cannot be calculated when there is only one participant.
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 ...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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: NumberUnit 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 ...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 ...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 ...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 occurren...
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 Outcome Measure Data
Analysis Population Description
Analysis Population Description
All randomized participants
Arm/Group Title
Sliding Scale Regular Insulin
Basal-bolus Therapy
Arm/Group Description :
Human regular insulin: Administered...
Insulin lispro: Administered subcut...
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: NumberUnit 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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 cr...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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 myocard...
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 Outcome Measure Data
Analysis Population Description
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...
Insulin lispro: Administered subcut...
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.
Go to
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...
Insulin lispro: Administered subcut...
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).
Sliding Scale Regular Insulin
Basal-bolus Therapy
Affected / at Risk (%)
Affected / at Risk (%)
Total
--/--
--/--
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
1/9 (11.11%)
1
0/7 (0.00%)
0
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 15.0
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
1/9 (11.11%)
1
1/7 (14.29%)
1
Investigations
High density lipoprotein decreased
0/9 (0.00%)
0
1/7 (14.29%)
1
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 15.0
Go to
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.
Go to
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.
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