A Study of Dulaglutide 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:
NCT01584232
First received: April 23, 2012
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: 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: Insulin glargine
Drug: Sulfonylureas (SU)
Drug: Biguanide (BG)

  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
LY2189265 + OAM

LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin Glargine + OAM

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).


Participant Flow:   Overall Study
    LY2189265 + OAM     Insulin Glargine + OAM  
STARTED     181     180  
Received at Least 1 Dose of Study Drug     181     180  
COMPLETED     173     177  
NOT COMPLETED     8     3  
Adverse Event                 3                 1  
Withdrawal by Subject                 2                 1  
Physician Decision                 2                 1  
Lost to Follow-up                 1                 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 randomized participants who received at least 1 dose of LY2189265 or insulin glargine.

Reporting Groups
  Description
LY2189265 + OAM

LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin Glargine + OAM

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Total Total of all reporting groups

Baseline Measures
    LY2189265 + OAM     Insulin Glargine + OAM     Total  
Number of Participants  
[units: participants]
  181     180     361  
Age  
[units: years]
Mean ± Standard Deviation
  57.52  ± 10.48     56.14  ± 11.33     56.83  ± 10.92  
Gender  
[units: participants]
     
Female     56     47     103  
Male     125     133     258  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     181     180     361  
Region of Enrollment  
[units: participants]
     
Japan     181     180     361  



  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:   Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks   [ Time Frame: Up to 26 weeks ]

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

4.  Secondary:   Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks   [ Time Frame: Baseline, Up to 26 weeks ]

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

6.  Secondary:   Percentage of Participants With Hypoglycemic Episodes   [ Time Frame: Baseline through 26 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: NCT01584232     History of Changes
Other Study ID Numbers: 14359, H9X-JE-GBDY
Study First Received: April 23, 2012
Results First Received: October 3, 2014
Last Updated: October 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare