A Study to Evaluate the Effect of LY2189265 on the Speed at Which Food and Drink Leaves the Stomach in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01215968
First received: October 5, 2010
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/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Biological: LY2189265
Drug: Placebo

  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
Placebo Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
LY2189265 Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.

Participant Flow:   Overall Study
    Placebo     LY2189265  
STARTED     13     25  
Received at Least 1 Dose of Study Drug     13     24 [1]
COMPLETED     11     18  
NOT COMPLETED     2     7  
Adverse Event                 0                 2  
Protocol Violation                 2                 4  
Not received study drug                 0                 1  
[1] 25 participants received placebo during Week 1.



  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.
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Reporting Groups
  Description
Placebo Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
LY2189265 Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
Total Total of all reporting groups

Baseline Measures
    Placebo     LY2189265     Total  
Number of Participants  
[units: participants]
  13     25     38  
Age  
[units: years]
Mean (Standard Deviation)
  52.0  (14.0)     58.9  (9.8)     56.5  (11.7)  
Gender  
[units: participants]
     
Female     2     5     7  
Male     11     20     31  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     13     25     38  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     3     1     4  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     10     24     34  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United Kingdom     13     25     38  



  Outcome Measures
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1.  Primary:   Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy   [ Time Frame: Days 3, 10,17, 24 and 31 ]

2.  Secondary:   Area Under the Curve (AUC) of Metformin   [ Time Frame: Days 3, 17 and 31 ]

3.  Secondary:   Maximum Concentration (Cmax) of Metformin   [ Time Frame: Days 3, 17 and 31 ]

4.  Secondary:   Time to Maximum Concentration (Tmax) of Metformin   [ Time Frame: Days 3, 17 and 31 ]

5.  Secondary:   Number of Participants With Clinically Significant Effects   [ Time Frame: Baseline through 5 weeks ]


  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: NCT01215968     History of Changes
Other Study ID Numbers: 13598, 2009-017305-11, H9X-EW-GBDM
Study First Received: October 5, 2010
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration