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Trial record 11 of 39 for:    LY2189265

A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01001104
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: LY2189265
Drug: Placebo

  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
0.75 mg LY2189265 Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
0.5 mg LY2189265 Administered by SC injection, QW for 12 weeks.
0.25 mg LY2189265 Administered by SC injection, QW for 12 weeks.
Placebo Administered by SC injection, QW for 12 weeks.

Participant Flow:   Overall Study
    0.75 mg LY2189265   0.5 mg LY2189265   0.25 mg LY2189265   Placebo
STARTED   35   37   36   37 
COMPLETED   33   36   35   34 
NOT COMPLETED   2   1   1   3 
Adverse Event                2                1                0                0 
Lost to Follow-up                0                0                1                0 
Entry Criteria Not Met                0                0                0                1 
Withdrawal by Subject                0                0                0                2 



  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
0.75 mg LY2189265 Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
0.5 mg LY2189265 Administered by SC injection, QW for 12 weeks.
0.25 mg LY2189265 Administered by SC injection, QW for 12 weeks.
Placebo Administered by SC injection, QW for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   0.75 mg LY2189265   0.5 mg LY2189265   0.25 mg LY2189265   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   37   36   37   145 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.23  (7.80)   52.50  (9.17)   52.26  (8.82)   51.70  (9.67)   52.17  (8.82) 
Gender 
[Units: Participants]
         
Female   7   14   9   8   38 
Male   28   23   27   29   107 
Race/Ethnicity, Customized 
[Units: Participants]
         
Japanese   35   37   36   37   145 
Region of Enrollment 
[Units: Participants]
         
Japan   35   37   36   37   145 
Percentage of Glycosylated Hemoglobin (HbA1c) 
[Units: Percentage of glycosylated hemoglobin]
Mean (Standard Deviation)
 8.01  (0.63)   7.98  (0.66)   8.05  (0.66)   7.98  (0.64)   8.00  (0.64) 
Fasting Blood Glucose (FBG) 
[Units: Milligrams per deciliter (mg/dL)]
Mean (Standard Deviation)
 156.51  (26.43)   150.95  (29.31)   158.75  (35.62)   159.65  (33.29)   156.45  (31.26) 


  Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks   [ Time Frame: Baseline, 12 weeks ]

2.  Secondary:   Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks   [ Time Frame: up to 12 weeks ]

3.  Secondary:   Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks   [ Time Frame: up to 12 weeks ]

4.  Secondary:   Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks   [ Time Frame: Baseline, 12 weeks ]

5.  Secondary:   Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks   [ Time Frame: Baseline, 12 weeks ]

6.  Secondary:   Change From Baseline in Total Body Weight at 12 Weeks   [ Time Frame: Baseline, 12 weeks ]

7.  Secondary:   Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks   [ Time Frame: Baseline, 12 weeks ]

8.  Secondary:   Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks   [ Time Frame: Baseline, 12 weeks ]

9.  Secondary:   Steady-State Concentrations of LY2189265   [ Time Frame: 12 weeks ]

10.  Secondary:   Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period   [ Time Frame: 12 weeks ]


  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: NCT01001104     History of Changes
Other Study ID Numbers: 12840
H9X-JE-GBCZ ( Other Identifier: Eli Lilly and Company )
First Submitted: October 22, 2009
First Posted: October 23, 2009
Results First Submitted: October 3, 2014
Results First Posted: September 28, 2015
Last Update Posted: September 28, 2015