Hyperglycemia
Conditions
Keywords
Hyperglycemia, Diabetes, Hospital, Diabetic
Brief summary
The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.
Detailed description
This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients. In this study, basal-bolus therapy will consist of once-daily glargine plus lispro 3 to 4 times daily adjusted to achieve pre-meal capillary plasma glucose \<140 milligrams per deciliter (mg/dL) and bedtime capillary plasma glucose \<180 mg/dL for patients who are eating \[predose plasma glucose \<140 mg/dL for patients with nil per os (NPO) orders\]; sliding scale insulin will be administered using human regular insulin 4 times daily as needed adjusted to achieve predose capillary plasma glucose target \<140 mg/dL in patients who are eating or have NPO orders.
Interventions
Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization)
DRUGInsulin lispro
Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
DRUGInsulin glargine
Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * No known history of diabetes * Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL * Non-critically ill and admitted to acute care medical services * Have a body mass index greater than or equal to 18.5 kg/m\^2 and less than or equal to 45 kilograms per square meter (kg/m\^2) Major
Exclusion criteria
* Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization * Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL * Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry * Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period * Expected hospitalization less than 24 hours post-randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Plasma Glucose (MPG) Throughout Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10. |
| Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TDD of Insulin (Units/kg) by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
| Mean Fasting Plasma Glucose (FPG) by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
| Mean FPG Throughout Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Length of Hospital Stay Post-randomization Throughout the Hospital Study Period | Throughout the hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period | Throughout the hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period | Throughout the hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period | Throughout the hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
| Mean Plasma Glucose (MPG) by Hospital Day | Day 1 up to day 7 of hospital study period | The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7. |
| TDD of Insulin (Units/kg) Throughout the Hospital Study Period | Throughout the hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| TDD of Insulin (Units) by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
| Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG \<40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. |
| Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG \<40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed. |
| Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day | Day 1 up to day 10 of hospital study period | Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG \<40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed. |
| Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day | Day 1 up to day 10 of hospital study period | Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG \<40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed. |
| Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Treatment-emergent adverse event - any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module. |
| Percentage of Participants Requiring Intensive Care Unit Transfer | Throughout hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period | Throughout hospital study period (1 to 10 days post-randomization) | Deterioration of renal function was defined by an increase in serum creatinine by \>0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Participants With Documented Nosocomial Infections | Throughout hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Number of Participants With Major Adverse Cardiovascular Events (MACE) | Throughout hospital study period (1 to 10 days post-randomization) | MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed. |
| Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period | Throughout the hospital study period (1 to 10 days post-randomization) | Due to low enrollment, this outcome measure was not analyzed. |
| Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day | Day 1 up to day 10 of hospital study period | Due to low enrollment, this outcome measure was not analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sliding Scale Regular Insulin Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization). | 9 |
| Basal-bolus Therapy 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). | 7 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 2 | 1 |
Baseline characteristics
| Characteristic | Sliding Scale Regular Insulin | Total | Basal-bolus Therapy |
|---|---|---|---|
| Age Continuous | 60.2 years STANDARD_DEVIATION 16.8 | 56.4 years STANDARD_DEVIATION 14.1 | 51.4 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 15 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 9 participants | 16 participants | 7 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 9 | 2 / 7 |
| serious Total, serious adverse events | 1 / 9 | 0 / 7 |
Outcome results
Primary
Mean Plasma Glucose (MPG) Throughout Hospital Study Period
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)
Population: All randomized participants who had at least one post-baseline glucose measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) Throughout Hospital Study Period | 167.6 milligrams per deciliter (mg/dL) | Standard Deviation 48.5 |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) Throughout Hospital Study Period | 128.4 milligrams per deciliter (mg/dL) | Standard Deviation 22.4 |
Primary
Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period
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)
Population: All randomized participants who had at least one post-baseline glucose measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sliding Scale Regular Insulin | Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period | 81.4 percentage of capillary PG measurements |
| Basal-bolus Therapy | Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period | 84.3 percentage of capillary PG measurements |
Secondary
Length of Hospital Stay Post-randomization Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout the hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Mean Fasting Plasma Glucose (FPG) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Mean FPG Throughout Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Mean Plasma Glucose (MPG) by Hospital Day
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
Population: All randomized participants who had at least one post-baseline glucose measurement and a plasma glucose measurement at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) by Hospital Day | Day 2 (n=8, n=5) | 175.2 mg/dL | Standard Deviation 57.9 |
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) by Hospital Day | Day 5 (n=1, n=1) | 154.8 mg/dL | — |
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) by Hospital Day | Day 1 (n=6, n=6) | 178.1 mg/dL | Standard Deviation 54.9 |
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) by Hospital Day | Day 6 (n=1, n=1) | 138.0 mg/dL | — |
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) by Hospital Day | Day 3 (n=6, n=3) | 151.0 mg/dL | Standard Deviation 46.9 |
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) by Hospital Day | Day 7 (n=0, n=1) | NA mg/dL | — |
| Sliding Scale Regular Insulin | Mean Plasma Glucose (MPG) by Hospital Day | Day 4 (n=2, n=1) | 132.5 mg/dL | Standard Deviation 2.12 |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) by Hospital Day | Day 7 (n=0, n=1) | 108.0 mg/dL | — |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) by Hospital Day | Day 1 (n=6, n=6) | 149.9 mg/dL | Standard Deviation 17.2 |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) by Hospital Day | Day 2 (n=8, n=5) | 124.0 mg/dL | Standard Deviation 29.8 |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) by Hospital Day | Day 4 (n=2, n=1) | 96.3 mg/dL | — |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) by Hospital Day | Day 5 (n=1, n=1) | 104.6 mg/dL | — |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) by Hospital Day | Day 6 (n=1, n=1) | 111.0 mg/dL | — |
| Basal-bolus Therapy | Mean Plasma Glucose (MPG) by Hospital Day | Day 3 (n=6, n=3) | 128.5 mg/dL | Standard Deviation 28.5 |
Secondary
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day
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
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG \<40 mg/dL (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)
Population: All randomized participants who had at least one post-baseline glucose measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sliding Scale Regular Insulin | Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period | Hypoglycemic Episodes | 1 hypoglycemic episodes |
| Sliding Scale Regular Insulin | Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period | Severe Hypoglycemic Episodes | 0 hypoglycemic episodes |
| Basal-bolus Therapy | Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period | Hypoglycemic Episodes | 3 hypoglycemic episodes |
| Basal-bolus Therapy | Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period | Severe Hypoglycemic Episodes | 0 hypoglycemic episodes |
Secondary
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day
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
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period
Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG \<40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Number of Participants With Major Adverse Cardiovascular Events (MACE)
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)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period
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)
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sliding Scale Regular Insulin | Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period | 1 participants |
| Basal-bolus Therapy | Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period | 2 participants |
Secondary
Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout the hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
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
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
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
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout the hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
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
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout the hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
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
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
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
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Percentage of Participants Requiring Intensive Care Unit Transfer
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period
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)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Percentage of Participants With Documented Nosocomial Infections
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
TDD of Insulin (Units) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
TDD of Insulin (Units/kg) by Hospital Day
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Day 1 up to day 10 of hospital study period
Population: Due to low enrollment, zero participants were analyzed.
Secondary
TDD of Insulin (Units/kg) Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout the hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.
Secondary
Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period
Due to low enrollment, this outcome measure was not analyzed.
Time frame: Throughout the hospital study period (1 to 10 days post-randomization)
Population: Due to low enrollment, zero participants were analyzed.