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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01644500
First received: July 17, 2012
Last updated: November 16, 2015
Last verified: November 2015
Results First Received: August 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Dulaglutide
Drug: Glimepiride
Drug: Placebo as Capsules
Drug: Placebo as SC Injection

  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
1.5 mg Dulaglutide 1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
0.75 mg Dulaglutide 0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
Glimepiride 1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.

Participant Flow:   Overall Study
    1.5 mg Dulaglutide     0.75 mg Dulaglutide     Glimepiride  
STARTED     268     268     271  
Received at Least One Dose of Study Drug     268     268     269  
Modified Intent-to-treat Population     263     259     268  
COMPLETED     244     240     253  
NOT COMPLETED     24     28     18  
Adverse Event                 7                 1                 2  
Death                 0                 1                 0  
Protocol Violation                 1                 1                 0  
Withdrawal by Subject                 11                 13                 12  
Physician Decision                 1                 1                 1  
Sponsor Decision                 0                 0                 1  
Lost to Follow-up                 4                 11                 2  



  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 is reported for the modified intent-to-treat population, who are all randomized participants with a baseline glycosylated hemoglobin (HbA1c) measurement, with at least 1 post-baseline HbA1c measurement, and who received at least one dose of study drug.

Reporting Groups
  Description
1.5 mg Dulaglutide 1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
0.75 mg Dulaglutide 0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
Glimepiride 1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
Total Total of all reporting groups

Baseline Measures
    1.5 mg Dulaglutide     0.75 mg Dulaglutide     Glimepiride     Total  
Number of Participants  
[units: participants]
  263     259     268     790  
Age  
[units: years]
Mean (Standard Deviation)
  52.99  (10.687)     53.73  (10.149)     51.68  (10.196)     52.79  (10.368)  
Gender  
[units: participants]
       
Female     118     123     123     364  
Male     145     136     145     426  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     263     259     268     790  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     0     0  
White     0     0     0     0  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
Taiwan     29     28     29     86  
China     208     206     212     626  
Korea, Republic of     26     25     27     78  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

2.  Secondary:   Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks   [ Time Frame: 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 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

5.  Secondary:   Rate of Hypoglycemic Episodes   [ Time Frame: Baseline through 26 Weeks ]

6.  Secondary:   Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks   [ Time Frame: Baseline, up to 26 Weeks ]

7.  Secondary:   Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks   [ Time Frame: Baseline, up to 26 Weeks ]

8.  Secondary:   Incidence of All Hypoglycemic Episodes   [ Time Frame: Baseline through 26 Weeks ]

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

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

11.  Secondary:   Change From Baseline in Sitting Blood Pressure at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

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

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

14.  Secondary:   Change From Baseline in Heart Rate From ECG at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

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

16.  Secondary:   Change From Baseline in Body Mass Index (BMI) at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

17.  Secondary:   Proportion of Participants Developing Antibodies to Dulaglutide   [ Time Frame: Baseline through 26 Weeks ]

18.  Secondary:   Number of Participants With Adjudicated Cardiovascular Events   [ Time Frame: Baseline through 26 Weeks ]

19.  Secondary:   Number of Participants With Adjudicated Pancreatitis   [ Time Frame: Baseline through 26 Weeks ]

20.  Secondary:   European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks   [ Time Frame: Week 26 ]

21.  Secondary:   Visual Analog Scale (VAS) Score at Week 26   [ Time Frame: Week 26 ]


  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: NCT01644500     History of Changes
Other Study ID Numbers: 11991
H9X-JE-GBCG ( Other Identifier: Eli Lilly and Company )
Study First Received: July 17, 2012
Results First Received: August 3, 2015
Last Updated: November 16, 2015
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Taiwan : Food and Drug Administration