Bioequivalence of Two Lispro Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01133392
First received: May 27, 2010
Last updated: December 29, 2014
Last verified: December 2014
Results First Received: October 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy Volunteers
Interventions: Drug: Insulin lispro A
Drug: Insulin lispro B

  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
41 participants were enrolled into the study. 3 participants discontinued due to subject decision prior to receiving treatment.

Reporting Groups
  Description
Insulin Lispro Dosing Sequence ABAB Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses.
Insulin Lispro Dosing Sequence BABA Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses.

Participant Flow for 7 periods

Period 1:   First Intervention (1 Day )
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA  
STARTED     20     18  
COMPLETED     20     18  
NOT COMPLETED     0     0  

Period 2:   Interval Between Dosing (4-7 Days)
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA  
STARTED     20     18  
COMPLETED     20     17  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  

Period 3:   Second Intervention (1 Day)
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA  
STARTED     20     17  
COMPLETED     20     17  
NOT COMPLETED     0     0  

Period 4:   Interval Between Dosing (4-7 Days)
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA  
STARTED     20     17  
COMPLETED     20     17  
NOT COMPLETED     0     0  

Period 5:   Third Intervention (1 Day)
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA  
STARTED     20     17  
COMPLETED     20     17  
NOT COMPLETED     0     0  

Period 6:   Interval Between Dosing (4-7 Days)
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA  
STARTED     20     17  
COMPLETED     20     16  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  

Period 7:   Fourth Intervention (1 Day)
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA  
STARTED     20     16  
COMPLETED     20     16  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Insulin Lispro Dosing Sequence ABAB Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB.
Insulin Lispro Dosing Sequence BABA Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA.
Total Total of all reporting groups

Baseline Measures
    Insulin Lispro Dosing Sequence ABAB     Insulin Lispro Dosing Sequence BABA     Total  
Number of Participants  
[units: participants]
  20     18     38  
Age  
[units: years]
Mean (Standard Deviation)
  30.4  (7.2)     34.6  (6.4)     32.4  (7.1)  
Gender  
[units: participants]
     
Female     0     2     2  
Male     20     16     36  
Race/Ethnicity, Customized  
[units: participants]
     
Not Hispanic or Latino     20     18     38  
Hispanic or Latino     0     0     0  
Region of Enrollment  
[units: participants]
     
Singapore     20     18     38  



  Outcome Measures
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1.  Primary:   Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]   [ Time Frame: 0 up to 8 hours post dose ]

2.  Secondary:   Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]   [ Time Frame: 0 to 8 hours post dose ]

3.  Secondary:   Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)   [ Time Frame: 0 to 8 hours post dose ]

4.  Secondary:   Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)   [ Time Frame: 0 to 8 hours post dose ]

5.  Secondary:   Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)   [ Time Frame: 0 to 8 hours post dose ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01133392     History of Changes
Other Study ID Numbers: 13300
F3Z-EW-IOPY ( Other Identifier: Eli Lilly and Company )
Study First Received: May 27, 2010
Results First Received: October 10, 2014
Last Updated: December 29, 2014
Health Authority: Singapore: Health Sciences Authority