A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes (AWARD-6)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01624259
First received: June 18, 2012
Last updated: October 3, 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
Interventions: Drug: LY2189265
Drug: Liraglutide
Drug: Metformin

  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
No text entered.

Reporting Groups
  Description
LY2189265

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks

Metformin: at least 1500 mg/day, oral, for 26 weeks

Liraglutide

Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks

Metformin: at least 1500 mg/day, oral, for 26 weeks


Participant Flow:   Overall Study
    LY2189265     Liraglutide  
STARTED     299     300  
Received at Least One Dose of Study Drug     299     300  
COMPLETED     269 [1]   269 [1]
NOT COMPLETED     30     31  
Adverse Event                 18                 18  
Protocol Violation                 1                 2  
Withdrawal by Subject                 5                 7  
Physician Decision                 1                 1  
Lost to Follow-up                 2                 3  
Abnormal laboratory measure                 3                 0  
[1] Completed the study on study treatment



  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 were randomized and received at least 1 dose of LY2189265 or Liraglutide

Reporting Groups
  Description
LY2189265

LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks

Metformin: at least 1500 mg/day, oral, for 26 weeks

Liraglutide

Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks

Metformin: at least 1500 mg/day, oral, for 26 weeks

Total Total of all reporting groups

Baseline Measures
    LY2189265     Liraglutide     Total  
Number of Participants  
[units: participants]
  299     300     599  
Age  
[units: years]
Mean ± Standard Deviation
  56.49  ± 9.34     56.81  ± 9.91     56.65  ± 9.63  
Gender  
[units: participants]
     
Female     161     151     312  
Male     138     149     287  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     75     72     147  
Not Hispanic or Latino     221     223     444  
Unknown or Not Reported     3     5     8  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     20     23     43  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     21     16     37  
White     256     259     515  
More than one race     1     2     3  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     97     97     194  
Czech Republic     27     28     55  
Hungary     21     19     40  
Mexico     20     21     41  
Slovakia     20     22     42  
Puerto Rico     3     4     7  
Poland     39     42     81  
Spain     24     24     48  
Romania     20     17     37  
Germany     28     26     54  
Study-Specific Measure  
[units: kilograms (kg)]
Mean ± Standard Deviation
  93.82  ± 18.23     94.35  ± 18.96     94.09  ± 18.58  
Study-Specific Measure [1]
[units: kilograms per meter squared (kg/m^2)]
Mean ± Standard Deviation
  33.50  ± 5.07     33.62  ± 5.16     33.56  ± 5.11  
Study-Specific Measure  
[units: percentage of glycosylated hemoglobin]
Mean ± Standard Deviation
  8.06  ± 0.81     8.05  ± 0.79     8.05  ± 0.80  
Study-Specific Measure  
[units: years]
Mean ± Standard Deviation
  7.13  ± 5.41     7.28  ± 5.41     7.21  ± 5.41  
[1] BMI is an estimate of body fat based on body weight divided by height squared



  Outcome Measures
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1.  Primary:   Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, 26 Weeks ]

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

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

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks   [ Time Frame: Baseline, Up to 26 Weeks ]

5.  Secondary:   Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

6.  Secondary:   Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks   [ Time Frame: Up to 26 Weeks ]

7.  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 ]

8.  Secondary:   Number of Participants With Reported and Adjudicated Cardiovascular Events   [ Time Frame: Baseline up to 26 Weeks ]

9.  Secondary:   Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks   [ Time Frame: Baseline, Up to 26 Weeks ]

10.  Secondary:   Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

11.  Secondary:   Change From Baseline in Heart Rate (HR) at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

12.  Secondary:   Change From Baseline in Blood Pressure (BP) at 26 Weeks   [ Time Frame: Baseline, 26 Weeks ]

13.  Secondary:   Number of Participants With Adjudicated Acute Pancreatitis Events   [ Time Frame: Baseline up to 30 Weeks ]

14.  Secondary:   Change From Baseline in Calcitonin at 26 Weeks   [ Time Frame: Baseline, Up to 26 Weeks ]

15.  Secondary:   Change From Baseline in Lipase at 26 Weeks   [ Time Frame: Baseline, Up to 26 Weeks ]

16.  Secondary:   Change From Baseline in Amylase at 26 Weeks   [ Time Frame: Baseline, Up to 26 Weeks ]

17.  Secondary:   Percentage of Participants With Self-Reported Hypoglycemia Events   [ Time Frame: Baseline through 26 Weeks ]

18.  Secondary:   Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia   [ Time Frame: Baseline through 26 Weeks ]

19.  Secondary:   Rate of Hypoglycemic Events Adjusted Per 30 Days   [ Time Frame: Baseline through 26 Weeks ]

20.  Secondary:   Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia   [ Time Frame: Baseline through 26 Weeks ]

21.  Secondary:   Number of Participants With Allergic or Hypersensitivity Reactions   [ Time Frame: Baseline through 26 Weeks ]

22.  Secondary:   Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose   [ Time Frame: Baseline up to 4 Weeks Post Last Dose of Study Drug ]

23.  Secondary:   Percent Change From Baseline in Lipid Parameters at 26 Weeks   [ Time Frame: Baseline, Up to 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 by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01624259     History of Changes
Other Study ID Numbers: 11377, H9X-MC-GBDE, 2011-003810-18
Study First Received: June 18, 2012
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Mexico: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Slovakia: State Institute for Drug Control