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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: May 20, 2015
Last verified: May 2015
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
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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 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
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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 1 dose of study medication.

Reporting Groups
  Description
LY2189265 Once-weekly SC injection of 0.75 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 
Overall Participants Analyzed 
[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
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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 ]

10.  Secondary:   30-Day Rate of Hypoglycemic Episodes   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks ]

11.  Secondary:   Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks ]

12.  Secondary:   Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

13.  Secondary:   Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

14.  Secondary:   Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks ]

15.  Secondary:   Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

16.  Secondary:   Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

17.  Secondary:   Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks ]

18.  Secondary:   Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks ]

19.  Secondary:   Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01558271     History of Changes
Other Study ID Numbers: 13990
H9X-JE-GBDP ( Other Identifier: Eli Lilly and Company )
Study First Received: March 12, 2012
Results First Received: October 22, 2014
Last Updated: May 20, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare