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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: May 30, 2017
Last verified: May 2017
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   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   258   257   259 
Received at Least One Dose of Study Drug   258   257   259 
Modified Intent-to-Treat Population   253   252   250 
COMPLETED   226   219   227 
NOT COMPLETED   32   38   32 
Adverse Event                6                11                2 
Lost to Follow-up                9                6                8 
Protocol Violation                1                2                1 
Withdrawal by Subject                15                17                17 
Physician Decision                0                1                3 
Death                1                0                0 
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 
Overall Participants Analyzed 
[Units: Participants]
 253   252   250   755 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.03  (9.572)   54.54  (10.006)   55.44  (9.197)   55.00  (9.593) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      118  46.6%      109  43.3%      111  44.4%      338  44.8% 
Male      135  53.4%      143  56.7%      139  55.6%      417  55.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      14   5.5%      14   5.6%      13   5.2%      41   5.4% 
Asian      213  84.2%      209  82.9%      209  83.6%      631  83.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      26  10.3%      29  11.5%      28  11.2%      83  11.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
China   200   196   195   591 
Korea, Republic of   13   13   14   40 
Mexico   22   24   24   70 
Russian Federation   18   19   17   54 


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

6.  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 ]

7.  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 ]

8.  Secondary:   Rate of Hypoglycemic Events   [ Time Frame: Baseline through 26 weeks and 52 weeks ]

9.  Secondary:   Number of Self-reported Hypoglycemic Events   [ Time Frame: Baseline through 26 Weeks and 52 Weeks ]

10.  Secondary:   Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

11.  Secondary:   Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

12.  Secondary:   Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

13.  Secondary:   Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

14.  Secondary:   Change From Baseline in Pancreatic Enzymes   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

15.  Secondary:   Change From Baseline in Serum Calcitonin   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

16.  Secondary:   Number of Participants With Adjudicated Cardiovascular (CV) Events   [ Time Frame: Baseline through 52 weeks ]

17.  Secondary:   Number of Participants With Adjudicated Pancreatitis   [ Time Frame: Baseline through 52 Weeks ]

18.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

19.  Secondary:   Change in Body Mass Index   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

20.  Secondary:   Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)   [ Time Frame: Baseline through 52 Weeks ]

21.  Secondary:   EQ-5D Health State Score Responses   [ Time Frame: Baseline, 26 Weeks, 52 Weeks ]

22.  Secondary:   Change From Baseline in EQ-5D Visual Analog Scale Score   [ 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: NCT01648582     History of Changes
Other Study ID Numbers: 13439
H9X-CR-GBDK ( Other Identifier: Eli Lilly and Company )
Study First Received: July 16, 2012
Results First Received: May 8, 2015
Last Updated: May 30, 2017