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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:
ClinicalTrials.gov Identifier:
NCT01474538
First Posted: November 18, 2011
Last Update Posted: March 20, 2014
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.
Information provided by (Responsible Party):
Eli Lilly and Company
Results First Submitted: February 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  More Information



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