Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
NCT01558271
First received: March 12, 2012
Last updated: October 22, 2014
Last verified: October 2014
Results First Received: October 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: LY2189265
Drug: Placebo
Drug: Liraglutide

  Participant Flow
  Hide 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
LY2189265 Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
Placebo/LY2189265 Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
Liraglutide Once-daily SC injection of 0.3 mg of Liraglutide for the first week followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.

Participant Flow:   Overall Study
    LY2189265     Placebo/LY2189265     Liraglutide  
STARTED     281     70     141  
Received at Least 1 Dose of Study Drug     280     70     137  
Completed 26 Weeks     271     63     128  
COMPLETED     263     59     124  
NOT COMPLETED     18     11     17  
Adverse Event                 6                 3                 4  
Lost to Follow-up                 1                 0                 0  
Protocol Violation                 1                 0                 0  
Withdrawal by Subject                 10                 6                 12  
Physician Decision                 0                 2                 1  



  Baseline Characteristics
  Hide 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 study medication.

Reporting Groups
  Description
LY2189265 Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
Placebo/LY2189265 Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
Liraglutide Once-daily SC injection of 0.3 mg of Liraglutide for the first week followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
Total Total of all reporting groups

Baseline Measures
    LY2189265     Placebo/LY2189265     Liraglutide     Total  
Number of Participants  
[units: participants]
  280     70     137     487  
Age  
[units: years]
Mean ± Standard Deviation
  57.15  ± 9.57     57.66  ± 8.34     57.91  ± 10.93     57.44  ± 9.63  
Gender  
[units: participants]
       
Female     52     15     24     91  
Male     228     55     113     396  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     280     70     137     487  
Region of Enrollment  
[units: participants]
       
Japan     280     70     137     487  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks   [ Time Frame: Baseline, 26 weeks ]

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

3.  Secondary:   Percentage of Participants Who Achieved HbA1c <=6.5% or <7%   [ Time Frame: Up to 26 and 52 weeks ]

4.  Secondary:   Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

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

6.  Secondary:   Change From Baseline in Body Weight at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

7.  Secondary:   Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

8.  Secondary:   Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

9.  Secondary:   Percentage of Participants With Hypoglycemic Episodes   [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01558271     History of Changes
Other Study ID Numbers: 13990, H9X-JE-GBDP
Study First Received: March 12, 2012
Results First Received: October 22, 2014
Last Updated: October 22, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare