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

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01136746
First received: June 2, 2010
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
Results First Received: September 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hyperglycemia
Interventions: Drug: Human regular insulin
Drug: Insulin lispro
Drug: Insulin glargine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Sliding Scale Regular Insulin     Basal-bolus Therapy  
STARTED     9     7  
COMPLETED     6     4  
NOT COMPLETED     3     3  
Lost to Follow-up                 0                 2  
Protocol Violation                 2                 1  
Death                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
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).
Total Total of all reporting groups

Baseline Measures
    Sliding Scale Regular Insulin     Basal-bolus Therapy     Total  
Number of Participants  
[units: participants]
 		  9     7     16  
Age  
[units: years]
Mean ± Standard Deviation 		  60.2  ± 16.8     51.4  ± 8.5     56.4  ± 14.1  
Gender  
[units: participants]
 		     
Female     5     2     7  
Male     4     5     9  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     8     7     15  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     2     7  
White     4     5     9  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     9     7     16  



  Outcome Measures
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1.  Primary:   Mean Plasma Glucose (MPG) Throughout Hospital Study Period   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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2.  Primary:   Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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3.  Secondary:   Mean Plasma Glucose (MPG) by Hospital Day   [ Time Frame: Day 1 up to day 7 of hospital study period ]
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4.  Secondary:   Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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5.  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   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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6.  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   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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7.  Secondary:   Mean Fasting Plasma Glucose (FPG) by Hospital Day   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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8.  Secondary:   Mean FPG Throughout Hospital Study Period   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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9.  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   [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
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10.  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   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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11.  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   [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
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12.  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   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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13.  Secondary:   Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period   [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
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14.  Secondary:   Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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15.  Secondary:   Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period   [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
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16.  Secondary:   TDD of Insulin (Units/kg) Throughout the Hospital Study Period   [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
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17.  Secondary:   TDD of Insulin (Units) by Hospital Day   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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18.  Secondary:   TDD of Insulin (Units/kg) by Hospital Day   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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19.  Secondary:   Length of Hospital Stay Post-randomization Throughout the Hospital Study Period   [ Time Frame: Throughout the hospital study period (1 to 10 days post-randomization) ]
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20.  Secondary:   Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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21.  Secondary:   Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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22.  Secondary:   Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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23.  Secondary:   Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day   [ Time Frame: Day 1 up to day 10 of hospital study period ]
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24.  Secondary:   Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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25.  Secondary:   Percentage of Participants Requiring Intensive Care Unit Transfer   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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26.  Secondary:   Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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27.  Secondary:   Percentage of Participants With Documented Nosocomial Infections   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
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28.  Secondary:   Number of Participants With Major Adverse Cardiovascular Events (MACE)   [ Time Frame: Throughout hospital study period (1 to 10 days post-randomization) ]
  Show Outcome Measure 28


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications:


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01136746     History of Changes
Other Study ID Numbers: 13698, F3Z-US-IOPZ
Study First Received: June 2, 2010
Results First Received: September 12, 2012
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration