A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01648582
First received: July 16, 2012
Last updated: June 29, 2015
Last verified: June 2015
Results First Received: May 8, 2015  
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: Dulaglutide
Drug: Insulin glargine
Drug: Metformin
Drug: Sulfonylureas

  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
This was a parallel-arm, non-inferiority study. Study treatment continued for up to 52 weeks and participants were randomized in a 1:1:1 ratio to one of the 3 treatment arms: 1.5 milligrams (mg) dulaglutide once-weekly , 0.75 mg dulaglutide once-weekly, or insulin glargine once-daily.

Reporting Groups
  Description
1.5 mg Dulaglutide 1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
0.75 mg Dulaglutide 0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
Insulin Glargine Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.

Participant Flow:   Overall Study
    1.5 mg Dulaglutide     0.75 mg Dulaglutide     Insulin Glargine  
STARTED     263     263     263  
Received at Least One Dose of Study Drug     263     263     257  
Modified Intent-to-Treat Population     258     258     254  
COMPLETED     231     225     231  
NOT COMPLETED     32     38     32  
Adverse Event                 6                 11                 2  
Death                 1                 0                 0  
Lost to Follow-up                 9                 6                 8  
Protocol Violation                 1                 2                 1  
Withdrawal by Subject                 15                 17                 17  
Physician Decision                 0                 1                 3  
Sponsor Decision                 0                 1                 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.
Baseline characteristics are reported for the modified intent-to-treat (mITT) population, who are all randomized participants with a baseline glycosylated hemoglobin (HbA1c) measurement, at least 1 post-baseline HbA1c measurement, and received at least 1 dose of study drug.

Reporting Groups
  Description
1.5 mg Dulaglutide 1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
0.75 mg Dulaglutide 0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
Insulin Glargine Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
Total Total of all reporting groups

Baseline Measures
    1.5 mg Dulaglutide     0.75 mg Dulaglutide     Insulin Glargine     Total  
Number of Participants  
[units: participants]
  258     258     254     770  
Age  
[units: years]
Mean (Standard Deviation)
  54.95  (9.742)     54.57  (9.924)     55.47  (9.215)     54.99  (9.629)  
Gender  
[units: participants]
       
Female     123     114     113     350  
Male     135     144     141     420  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     14     14     13     41  
Asian     218     215     213     646  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     0     0  
White     26     29     28     83  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
Mexico     22     24     24     70  
Russian Federation     18     19     17     54  
China     205     202     199     606  
Korea, Republic of     13     13     14     40  



  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 Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks   [ 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 Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

6.  Secondary:   Rate of Hypoglycemic Episodes   [ Time Frame: Baseline through 26 weeks or 52 weeks ]

7.  Secondary:   Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

8.  Secondary:   Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) 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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01648582     History of Changes
Other Study ID Numbers: 13439, H9X-CR-GBDK
Study First Received: July 16, 2012
Results First Received: May 8, 2015
Last Updated: June 29, 2015
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Mexico: Ministry of Health