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
No text entered.

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  
Number of Participants  
[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  
Study-Specific Measure  
[units: kilograms (kg)]
Mean ± Standard Deviation
  91.00  ± 18.24     91.69  ± 18.03     90.75  ± 18.87     91.14  ± 18.37  
Study-Specific Measure [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  
Study-Specific Measure  
[units: percentage of glycosylated hemoglobin]
Mean ± Standard Deviation
  8.46  ± 1.08     8.40  ± 1.03     8.53  ± 1.03     8.46  ± 1.05  
Study-Specific Measure  
[units: years]
Mean ± Standard Deviation
  12.80  ± 7.19     12.43  ± 6.92     12.96  ± 6.80     12.73  ± 6.97  
[1] Body mass index 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-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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01191268     History of Changes
Other Study ID Numbers: 11376, H9X-MC-GBDD
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