A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01468181
First received: November 7, 2011
Last updated: January 16, 2015
Last verified: January 2015
Results First Received: December 8, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: LY2189265
Drug: Sulfonylureas (SU)
Drug: Biguanides (BG)
Drug: alpha-glucosidase inhibitor (a-GI)
Drug: Thiazolidinedione (TZD)
Drug: Glinides

  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
No text entered.

Reporting Groups
  Description
LY2189265 + Sulfonylureas (SU)

LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.

LY2189265 + Biguanides (BG)

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.

LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.

LY2189265 + Thiazolidin Edione (TZD)

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.

LY2189265 + Glinides

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.


Participant Flow:   Overall Study
    LY2189265 + Sulfonylureas (SU)     LY2189265 + Biguanides (BG)     LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)     LY2189265 + Thiazolidin Edione (TZD)     LY2189265 + Glinides  
STARTED     131     61     65     66     71  
Received at Least 1 Dose of Study Drug     131     61     65     66     71  
COMPLETED     121     59     57     63     66  
NOT COMPLETED     10     2     8     3     5  
Adverse Event                 8                 1                 6                 2                 2  
Protocol Violation                 2                 0                 1                 0                 1  
Physician Decision                 0                 0                 0                 1                 1  
Lost to Follow-up                 0                 0                 1                 0                 1  
Withdrawal by Subject                 0                 1                 0                 0                 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.
All enrolled participants

Reporting Groups
  Description
LY2189265 + SU

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.

LY2189265 + BG

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.

LY2189265 + a-GI

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.

LY2189265 + TZD

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.

LY2189265 + Glinides

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.

Total Total of all reporting groups

Baseline Measures
    LY2189265 + SU     LY2189265 + BG     LY2189265 + a-GI     LY2189265 + TZD     LY2189265 + Glinides     Total  
Number of Participants  
[units: participants]
  131     61     65     66     71     394  
Age  
[units: years]
Mean ± Standard Deviation
  58.68  ± 11.59     52.69  ± 10.19     59.13  ± 10.51     56.40  ± 10.51     58.17  ± 10.30     57.35  ± 10.96  
Gender  
[units: participants]
           
Female     36     21     10     14     17     98  
Male     95     40     55     52     54     296  
Race (NIH/OMB)  
[units: participants]
           
American Indian or Alaska Native     0     0     0     0     0     0  
Asian     131     61     65     66     71     394  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0  
Black or African American     0     0     0     0     0     0  
White     0     0     0     0     0     0  
More than one race     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
           
Japan     131     61     65     66     71     394  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: Baseline through 52 Weeks ]

2.  Primary:   Percentage of Participants With Hypoglycemic Episodes   [ Time Frame: Baseline through 52 Weeks ]

3.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, up to 26 Weeks and up to 52 Weeks ]

4.  Secondary:   Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%   [ Time Frame: 26 weeks and 52 weeks ]

5.  Secondary:   Change From Baseline in Fasting Blood Glucose (FBG)   [ Time Frame: Baseline, up to 26 weeks and up to 52 weeks ]

6.  Secondary:   Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)   [ Time Frame: Baseline, up to 26 weeks and up to 52 weeks ]

7.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, up to 26 weeks and up to 52 weeks ]

8.  Secondary:   Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)   [ Time Frame: Baseline, up to 26 weeks and up to 52 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: NCT01468181     History of Changes
Other Study ID Numbers: 13991, H9X-JE-GBDQ
Study First Received: November 7, 2011
Results First Received: December 8, 2014
Last Updated: January 16, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare