Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01474538
First received: November 15, 2011
Last updated: February 4, 2014
Last verified: February 2014
Results First Received: February 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Insulin Lispro
Drug: Insulin Aspart

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Insulin Lispro / Insulin Aspart Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Insulin Aspart / Insulin Lispro Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Insulin Lispro / Insulin Aspart     Insulin Aspart / Insulin Lispro  
STARTED     60     62  
Received at Least 1 Dose of Study Drug     60     62  
COMPLETED     57     58  
NOT COMPLETED     3     4  
Death                 1                 0  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 3  
Protocol Violation                 0                 1  

Period 2:   Treatment Period 2
    Insulin Lispro / Insulin Aspart     Insulin Aspart / Insulin Lispro  
STARTED     57     58  
Received at Least 1 Dose of Study Drug     57     58  
COMPLETED     51     56  
NOT COMPLETED     6     2  
Death                 1                 0  
Adverse Event                 1                 1  
Withdrawal by Subject                 2                 0  
Sponsor decision                 1                 0  
Physician Decision                 0                 1  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Insulin Lispro / Insulin Aspart Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Insulin Aspart / Insulin Lispro Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
Total Total of all reporting groups

Baseline Measures
    Insulin Lispro / Insulin Aspart     Insulin Aspart / Insulin Lispro     Total  
Number of Participants  
[units: participants]
  60     62     122  
Age  
[units: years]
Mean ± Standard Deviation
  58.73  ± 10.41     60.40  ± 9.72     59.58  ± 10.06  
Gender  
[units: participants]
     
Female     33     32     65  
Male     27     30     57  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     5     10  
White     53     54     107  
More than one race     1     1     2  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     58     61     119  
Region of Enrollment  
[units: participants]
     
United States     60     62     122  



  Outcome Measures
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1.  Primary:   Glycosylated Hemoglobin A1C (HbA1c) at Endpoint   [ Time Frame: After 16 weeks of each treatment (Periods1 and 2) ]

2.  Secondary:   Total Daily Insulin Dose   [ Time Frame: Week 16 of each treatment (Periods 1 and 2) ]

3.  Secondary:   Rate of Hypoglycemic Events Per 30 Days   [ Time Frame: Baseline through 16 weeks of each treatment (Periods 1 and 2) ]

4.  Secondary:   Change From Baseline in Weight   [ Time Frame: Baseline, Week 16 of treatment Periods 1 and 2 ]

5.  Secondary:   Percentage of Participants With Hypoglycemic Events   [ Time Frame: Baseline through 16 weeks of each treatment (Periods 1 and 2) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01474538     History of Changes
Other Study ID Numbers: 14207, F3Z-MC-IOQH
Study First Received: November 15, 2011
Results First Received: February 4, 2014
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration