A Study of LY2189265 and Sitagliptin in Participants With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01408888
First received: August 2, 2011
Last updated: October 3, 2014
Last verified: October 2014
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: LY2189265
Drug: Sitagliptin

  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
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Reporting Groups
  Description
LY2189265, Sitagliptin + LY2189265

First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).

Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).

There was a washout of at least 21 days between treatments.

Sitagliptin + LY2189265, LY2189265

First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).

Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).

There was a washout of at least 21 days between treatments.


Participant Flow for 3 periods

Period 1:   First Intervention
    LY2189265, Sitagliptin + LY2189265     Sitagliptin + LY2189265, LY2189265  
STARTED     18     11  
Received at Least 1 Dose of Drug     18     11  
COMPLETED     18     8  
NOT COMPLETED     0     3  
Adverse Event                 0                 1  
Withdrawal by Subject                 0                 2  

Period 2:   Washout of at Least 21 Days
    LY2189265, Sitagliptin + LY2189265     Sitagliptin + LY2189265, LY2189265  
STARTED     18     8  
COMPLETED     18     8  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    LY2189265, Sitagliptin + LY2189265     Sitagliptin + LY2189265, LY2189265  
STARTED     18     8  
COMPLETED     16     8  
NOT COMPLETED     2     0  
Withdrawal by Subject                 1                 0  
Adverse Event                 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.
Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).

Reporting Groups
  Description
Entire Study Population Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Mean ± Standard Deviation
  52.7  ± 11.1  
Gender  
[units: participants]
 
Female     10  
Male     19  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     5  
Not Hispanic or Latino     24  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     4  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     14  
White     11  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     29  



  Outcome Measures
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1.  Primary:   Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin   [ Time Frame: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2 ]

2.  Primary:   Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin   [ Time Frame: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2 ]

3.  Secondary:   Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin   [ Time Frame: Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2 ]

4.  Secondary:   Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265   [ Time Frame: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2 ]

5.  Secondary:   Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265   [ Time Frame: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2 ]

6.  Secondary:   Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265   [ Time Frame: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 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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  More Information
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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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01408888     History of Changes
Other Study ID Numbers: 14361, H9X-MC-GBDW
Study First Received: August 2, 2011
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration