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Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8) (AWARD-8)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769378
First received: January 14, 2013
Last updated: December 18, 2015
Last verified: December 2015
Results First Received: September 14, 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: Placebo
Drug: Dulaglutide
Drug: Glimepiride

  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
Dulaglutide Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.

Participant Flow:   Overall Study
    Dulaglutide   Placebo
STARTED   240   60 
Received at Least 1 Dose of Study Drug   239   60 
COMPLETED   215 [1]   56 [1] 
NOT COMPLETED   25   4 
Adverse Event                10                0 
Entry criteria not met                1                0 
Protocol Violation                1                1 
Withdrawal by Subject                10                3 
Sponsor Decision                1                0 
Lost to Follow-up                2                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.
Intent to treat (ITT) population: all randomized participants who received at least one dose of study drug.

Reporting Groups
  Description
Dulaglutide Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Total Total of all reporting groups

Baseline Measures
   Dulaglutide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 239   60   299 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   182   49   231 
>=65 years   57   11   68 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.73  (10.20)   58.23  (7.40)   57.83  (9.70) 
Gender 
[Units: Participants]
     
Female   135   32   167 
Male   104   28   132 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   112   27   139 
Not Hispanic or Latino   127   33   160 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   21   5   26 
Asian   3   2   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   7   4   11 
White   202   47   249 
More than one race   6   2   8 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Argentina   29   8   37 
Austria   4   1   5 
Romania   78   18   96 
United States   57   14   71 
South Africa   7   3   10 
Mexico   40   10   50 
Slovenia   13   3   16 
Croatia   9   2   11 
Puerto Rico   2   1   3 


  Outcome Measures
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1.  Primary:   Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks   [ Time Frame: Baseline, 24 Weeks ]

2.  Secondary:   Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks   [ Time Frame: 24 Weeks ]

3.  Secondary:   Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks   [ Time Frame: Baseline, 24 Weeks ]

4.  Secondary:   Change From Baseline in Body Weight at 24 Weeks   [ Time Frame: Baseline, 24 Weeks ]

5.  Secondary:   Change From Baseline in Body Mass Index (BMI) at 24 Weeks   [ Time Frame: Baseline, 24 Weeks ]

6.  Secondary:   Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks   [ Time Frame: Baseline, 24 Weeks ]

7.  Secondary:   Number of Participants With Reported and Adjudicated Cardiovascular Events   [ Time Frame: Baseline through 24 Weeks, 30-day Follow Up ]

8.  Secondary:   Number of Participants With Adjudicated Acute Pancreatitis Events   [ Time Frame: Baseline through 24 Weeks, 30-day Follow Up ]

9.  Secondary:   Change From Baseline in Calcitonin at 24 Weeks   [ Time Frame: Baseline, 24 Weeks ]

10.  Secondary:   Percentage of Participants With Self-Reported Events of Hypoglycemia   [ Time Frame: Baseline through 24 Weeks ]

11.  Secondary:   Rate of HE Adjusted Per 30 Days   [ Time Frame: Baseline through 24 weeks ]

12.  Secondary:   Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia   [ Time Frame: Baseline through 24 Weeks ]

13.  Secondary:   Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia   [ Time Frame: Baseline through 24 Weeks ]

14.  Secondary:   Dulaglutide Anti-Drug Antibodies (ADA)   [ Time Frame: Baseline up to 4 Weeks Post-Last Dose of Study Drug ]

15.  Secondary:   Change From Baseline in Lipase   [ Time Frame: Baseline, 24 Weeks ]

16.  Secondary:   Change From Baseline in Amylase   [ Time Frame: Baseline, 24 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: NCT01769378     History of Changes
Other Study ID Numbers: 13193
H9X-MC-GBDG ( Other Identifier: Eli Lilly and Company )
Study First Received: January 14, 2013
Results First Received: September 14, 2015
Last Updated: December 18, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Mexico: Ministry of Health
South Africa: Medicines Control Council
Slovenia: Agency for Medicinal Products - Ministry of Health
Croatia: Agency for Medicinal Product and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency
Romania: National Agency for Medicines and Medical Devices