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Trial record 1 of 39 for:    LY2189265
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A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT01301092
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type II
Intervention: Biological: LY2189265

  Participant Flow

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
Part A: LY2189265 Intravenous Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
Part B: LY2189265 Subcutaneous, Intravenous Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
Part C: LY2189265 Subcutaneous, Intramuscular Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.

Participant Flow:   Overall Study
    Part A: LY2189265 Intravenous   Part B: LY2189265 Subcutaneous, Intravenous   Part C: LY2189265 Subcutaneous, Intramuscular
STARTED   6   16   8 
COMPLETED   6   16   7 
NOT COMPLETED   0   0   1 
Lost to Follow-up                0                0                1 



  Baseline Characteristics

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
Part A: LY2189265 Intravenous Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265
Part B: LY2189265 Subcutaneous, Intravenous Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
Part C: LY2189265 Subcutaneous, Intramuscular Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
Total Total of all reporting groups

Baseline Measures
   Part A: LY2189265 Intravenous   Part B: LY2189265 Subcutaneous, Intravenous   Part C: LY2189265 Subcutaneous, Intramuscular   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   16   8   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.0  (13.1)   42.3  (15.0)   45.6  (16.6)   44.10  (14.71) 
Gender 
[Units: Participants]
       
Female   3   4   3   10 
Male   3   12   5   20 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   1   0   0   1 
Not Hispanic or Latino   5   16   8   29 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   0   2   3   5 
White   6   14   5   25 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   6   16   8   30 


  Outcome Measures

1.  Primary:   Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)   [ Time Frame: Predose up to 336 hours postdose ]

2.  Primary:   Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)   [ Time Frame: Predose up to 336 hours postdose ]

3.  Secondary:   Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)   [ Time Frame: Predose up to 336 hours postdose ]

4.  Secondary:   )Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)   [ Time Frame: Predose up to 336 hours postdose ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01301092     History of Changes
Other Study ID Numbers: 13989
H9X-MC-GBDR ( Other Identifier: Eli Lilly and Company )
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: October 3, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014