Trial Outcomes & Findings for Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin (NCT NCT01136746)

NCT ID: NCT01136746

Last Updated: 2012-11-13

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 16 participants
• Primary outcome timeframe: Throughout hospital study period (1 to 10 days post-randomization)
• Results posted on: 2012-11-13

Participant Flow

Participant milestones

Measure	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).	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).
Overall Study STARTED	9	7
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	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).	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).
Overall Study Lost to Follow-up	0	2
Overall Study Protocol Violation	2	1
Overall Study Death	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sliding Scale Regular Insulin n=9 Participants Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=7 Participants 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 n=16 Participants Total of all reporting groups
Age Continuous	60.2 years STANDARD_DEVIATION 16.8 • n=5 Participants	51.4 years STANDARD_DEVIATION 8.5 • n=7 Participants	56.4 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

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

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

Outcome measures

Measure	Sliding Scale Regular Insulin n=9 Participants Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=6 Participants 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).
Mean Plasma Glucose (MPG) Throughout Hospital Study Period	167.6 milligrams per deciliter (mg/dL) Standard Deviation 48.5	128.4 milligrams per deciliter (mg/dL) Standard Deviation 22.4

PRIMARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

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

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.

Outcome measures

Measure	Sliding Scale Regular Insulin n=9 Participants Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=51 capillary plasma glucose measurements 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).
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	84.3 percentage of capillary PG measurements

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sliding Scale Regular Insulin n=9 Participants Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=6 Participants 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).
Mean Plasma Glucose (MPG) by Hospital Day Day 2 (n=8, n=5)	175.2 mg/dL Standard Deviation 57.9	124.0 mg/dL Standard Deviation 29.8
Mean Plasma Glucose (MPG) by Hospital Day Day 1 (n=6, n=6)	178.1 mg/dL Standard Deviation 54.9	149.9 mg/dL Standard Deviation 17.2
Mean Plasma Glucose (MPG) by Hospital Day Day 3 (n=6, n=3)	151.0 mg/dL Standard Deviation 46.9	128.5 mg/dL Standard Deviation 28.5
Mean Plasma Glucose (MPG) by Hospital Day Day 4 (n=2, n=1)	132.5 mg/dL Standard Deviation 2.12	96.3 mg/dL Standard Deviation NA Standard Deviation cannot be calculated when there is only one participant.
Mean Plasma Glucose (MPG) by Hospital Day Day 5 (n=1, n=1)	154.8 mg/dL Standard Deviation NA Standard Deviation cannot be calculated when there is only one participant.	104.6 mg/dL Standard Deviation NA Standard Deviation cannot be calculated when there is only one participant.
Mean Plasma Glucose (MPG) by Hospital Day Day 6 (n=1, n=1)	138.0 mg/dL Standard Deviation NA Standard Deviation cannot be calculated when there is only one participant.	111.0 mg/dL Standard Deviation NA Standard Deviation cannot be calculated when there is only one participant.
Mean Plasma Glucose (MPG) by Hospital Day Day 7 (n=0, n=1)	NA mg/dL Standard Deviation NA Cannot calculate a Mean or Standard Deviation with zero participants.	108.0 mg/dL Standard Deviation NA Standard Deviation cannot be calculated when there is only one participant.

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

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

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.

Outcome measures

Measure	Sliding Scale Regular Insulin n=9 Participants Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=6 Participants 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).
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period Hypoglycemic Episodes	1 hypoglycemic episodes	3 hypoglycemic episodes
Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period Severe Hypoglycemic Episodes	0 hypoglycemic episodes	0 hypoglycemic episodes

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to day 10 of hospital study period

Population: Due to low enrollment, zero participants were analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: All randomized participants

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.

Outcome measures

Measure	Sliding Scale Regular Insulin n=9 Participants Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=7 Participants 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).
Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period	1 participants	2 participants

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout hospital study period (1 to 10 days post-randomization)

Population: Due to low enrollment, zero participants were analyzed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Sliding Scale Regular Insulin

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Basal-bolus Therapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sliding Scale Regular Insulin n=9 participants at risk Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=7 participants at risk 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).
Cardiac disorders Myocardial infarction	11.1% 1/9 • Number of events 1	0.00% 0/7

Other adverse events

Measure	Sliding Scale Regular Insulin n=9 participants at risk Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).	Basal-bolus Therapy n=7 participants at risk 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).
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1	14.3% 1/7 • Number of events 1
Investigations High density lipoprotein decreased	0.00% 0/9	14.3% 1/7 • Number of events 1

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60