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
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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
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


  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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