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A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01191268
First received: August 27, 2010
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: Diabetes Mellitus, Type 2
Interventions: Drug: Insulin Glargine
Drug: LY2189265
Drug: Insulin Lispro

  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
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Reporting Groups
  Description
1.5 mg LY2189265

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

0.75 mg LY2189265

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Insulin Glargine

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks


Participant Flow:   Overall Study
    1.5 mg LY2189265   0.75 mg LY2189265   Insulin Glargine
STARTED   295   293   296 
Received at Least One Dose of Study Drug   295   293   296 
COMPLETED   237   238   244 
NOT COMPLETED   58   55   52 
Withdrawal by Subject                19                25                21 
Adverse Event                21                13                8 
Physician Decision                6                8                9 
Lost to Follow-up                8                5                9 
Entry Criteria Not Met                3                1                1 
Death                0                1                3 
Protocol Violation                1                0                1 
Sponsor Decision                0                2                0 



  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 Insulin Glargine.

Reporting Groups
  Description
1.5 mg LY2189265

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

0.75 mg LY2189265

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Insulin Glargine

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks

Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Total Total of all reporting groups

Baseline Measures
   1.5 mg LY2189265   0.75 mg LY2189265   Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 295   293   296   884 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.88  (9.55)   59.31  (8.98)   59.90  (9.08)   59.36  (9.21) 
Gender 
[Units: Participants]
       
Female   135   145   131   411 
Male   160   148   165   473 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   102   101   100   303 
Not Hispanic or Latino   193   192   196   581 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   16   13   17   46 
Asian   9   12   14   35 
Native Hawaiian or Other Pacific Islander   0   0   1   1 
Black or African American   32   27   26   85 
White   231   235   231   697 
More than one race   7   6   7   20 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   103   95   96   294 
Taiwan   8   9   9   26 
Greece   8   7   8   23 
Spain   8   10   9   27 
Russian Federation   6   8   9   23 
Hungary   19   19   19   57 
Mexico   19   19   17   55 
Canada   9   8   9   26 
Puerto Rico   13   20   18   51 
Argentina   26   27   28   81 
Poland   13   13   14   40 
Brazil   33   30   32   95 
Belgium   5   5   4   14 
Denmark   4   4   4   12 
Australia   10   8   8   26 
Sweden   11   11   12   34 
Body Weight 
[Units: Kilograms (kg)]
Mean (Standard Deviation)
 91.00  (18.24)   91.69  (18.03)   90.75  (18.87)   91.14  (18.37) 
Body Mass Index (BMI) [1] 
[Units: Kilograms per square meter (kg/m^2)]
Mean (Standard Deviation)
 31.99  (5.11)   33.08  (5.15)   32.41  (5.33)   32.49  (5.21) 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
Glycosylated Hemoglobin (HbA1c) 
[Units: Percentage of glycosylated hemoglobin]
Mean (Standard Deviation)
 8.46  (1.08)   8.40  (1.03)   8.53  (1.03)   8.46  (1.05) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 12.80  (7.19)   12.43  (6.92)   12.96  (6.80)   12.73  (6.97) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, 26 weeks ]

2.  Secondary:   Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, 52 weeks ]

3.  Secondary:   Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52   [ Time Frame: 26 weeks and 52 weeks ]

4.  Secondary:   Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

5.  Secondary:   Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

6.  Secondary:   Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

7.  Secondary:   Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)   [ Time Frame: Baseline and 26 weeks and 52 weeks ]

8.  Secondary:   Change From Baseline to 26 and 52 Weeks in Body Weight   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

9.  Secondary:   Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ]

10.  Secondary:   Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

11.  Secondary:   Change From Baseline to 26 and 52 Weeks in the EQ-5D   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

12.  Secondary:   Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

13.  Secondary:   Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

14.  Secondary:   Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

15.  Secondary:   Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

16.  Secondary:   Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ]

17.  Secondary:   Change From Baseline to 26 and 52 Weeks in Serum Calcitonin   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

18.  Secondary:   Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ]

19.  Secondary:   Change From Baseline to 26 and 52 Weeks in Blood Pressure   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

20.  Secondary:   Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ]

21.  Secondary:   Change From Baseline to 26 and 52 Weeks in Pulse Rate   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

22.  Secondary:   Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline and 52 weeks and 4 weeks after last dose ]

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

24.  Secondary:   Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

25.  Secondary:   Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline through 52 weeks ]

26.  Secondary:   Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline through 26 weeks and 52 weeks ]

27.  Secondary:   Rate of Self-reported Hypoglycemic Events up to 52 Weeks   [ Time Frame: Baseline through 52 weeks ]

28.  Secondary:   Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks   [ Time Frame: Baseline through 52 weeks ]

29.  Secondary:   Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline through 4 weeks after last dose ]

30.  Secondary:   Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose   [ Time Frame: Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01191268     History of Changes
Other Study ID Numbers: 11376
H9X-MC-GBDD ( Other Identifier: Eli Lilly and Company )
Study First Received: August 27, 2010
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: National Health and Medical Research Council
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Canada
Denmark: Danish Medicines Agency
Greece: Ministry of Health and Welfare
Hungary: Institutional Ethics Committee
Mexico: Ministry of Health
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Africa: Human Research Ethics Committee
Spain: Ministry of Health
Taiwan: Center for Drug Evaluation