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Trial record 37 of 39 for:    LY2189265

A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe

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ClinicalTrials.gov Identifier: NCT01524770
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : October 22, 2014
Last Update Posted : October 22, 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 2
Intervention: Biological: Dulaglutide

  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
Manual Syringe First, Then Auto-injector

First Intervention:

Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.

There was a washout period of at least 28 days between treatment periods.

Second intervention:

Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector.

Auto-injector First, Then Manual Syringe

First Intervention:

Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.

There was a washout period of at least 28 days between treatment periods.

Second intervention:

Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe.


Participant Flow for 3 periods

Period 1:   First Intervention
    Manual Syringe First, Then Auto-injector   Auto-injector First, Then Manual Syringe
STARTED   26   24 
Received at Least 1 Dose of Study Drug   26   24 
COMPLETED   23   23 
NOT COMPLETED   3   1 
Withdrawal by Subject                1                0 
Adverse Event                1                1 
Protocol Violation                1                0 

Period 2:   Washout Period of at Least 28 Days
    Manual Syringe First, Then Auto-injector   Auto-injector First, Then Manual Syringe
STARTED   23   23 
COMPLETED   23   23 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Manual Syringe First, Then Auto-injector   Auto-injector First, Then Manual Syringe
STARTED   23   23 
COMPLETED   23   23 
NOT COMPLETED   0   0 



  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.
Participants who received at least 1 dose of dulaglutide.

Reporting Groups
  Description
Entire Study Population All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.3  (17.2) 
Gender 
[Units: Participants]
 
Female   10 
Male   40 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   14 
Not Hispanic or Latino   36 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   12 
White   35 
More than one race   3 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   50 


  Outcome Measures

1.  Primary:   Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide   [ Time Frame: Predose to 336 hours postdose ]

2.  Primary:   Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide   [ Time Frame: Predose to 336 hours postdose ]

3.  Secondary:   Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide   [ Time Frame: Predose 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: NCT01524770     History of Changes
Other Study ID Numbers: 14142
H9X-MC-GBDT ( Other Identifier: Eli Lilly and Company )
First Submitted: January 31, 2012
First Posted: February 2, 2012
Results First Submitted: October 3, 2014
Results First Posted: October 22, 2014
Last Update Posted: October 22, 2014