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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01075282
First received: February 23, 2010
Last updated: January 15, 2015
Last verified: January 2015
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: Metformin
Drug: Glimepiride

  Participant Flow
  Hide Participant Flow

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
LY2189265 1.5 mg

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks

Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks

LY2189265 0.75 mg

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks

Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks

Insulin Glargine

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks

Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks


Participant Flow:   Overall Study
    LY2189265 1.5 mg   LY2189265 0.75 mg   Insulin Glargine
STARTED   273   272   265 [1] 
Received at Least One Dose of Study Drug   273   272   262 
COMPLETED   242   243   238 
NOT COMPLETED   31   29   27 
Withdrawal by Subject                11                7                11 
Adverse Event                9                8                5 
Entry Criteria Not Met                3                2                0 
Lost to Follow-up                3                3                3 
Physician Decision                3                3                3 
Lack of Efficacy                1                1                0 
Treatment Non-compliance                1                2                2 
Protocol Violation                0                2                1 
Death                0                1                2 
[1] Of 265 participants randomized to Insulin Glargine, 3 chose not to take study drug.



  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
LY2189265 1.5 mg

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks

Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks

LY2189265 0.75 mg

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks

Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks

Insulin Glargine

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks

Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks

Glimepiride: at least 4 mg/day, oral, for 78 weeks

Total Total of all reporting groups

Baseline Measures
   LY2189265 1.5 mg   LY2189265 0.75 mg   Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 273   272   262   807 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.24  (9.76)   56.56  (9.27)   57.21  (9.38)   56.66  (9.47) 
Gender 
[Units: Participants]
       
Female   129   136   128   393 
Male   144   136   134   414 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   98   96   97   291 
Not Hispanic or Latino   175   176   165   516 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   29   31   29   89 
Asian   48   46   43   137 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   1   1   2   4 
White   193   193   184   570 
More than one race   2   1   4   7 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Taiwan   13   13   12   38 
Slovakia   1   1   0   2 
Greece   6   6   7   19 
Spain   10   12   13   35 
Italy   2   3   1   6 
India   30   27   27   84 
France   2   3   1   6 
Czech Republic   12   14   13   39 
Hungary   16   16   15   47 
Mexico   29   28   27   84 
Canada   26   25   24   75 
Argentina   55   54   54   163 
Belgium   7   5   3   15 
Brazil   6   5   7   18 
Poland   16   18   17   51 
Croatia   3   4   4   11 
Romania   23   22   22   67 
Australia   13   13   13   39 
Sweden   2   0   1   3 
Korea, Republic of   1   3   1   5 
Body Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 85.13  (17.90)   86.18  (18.15)   87.66  (19.62)   86.31  (18.56) 
Body Mass Index (BMI) [1] 
[Units: Kilograms per square meter (kg/m^2)]
Mean (Standard Deviation)
 31.23  (5.21)   31.51  (5.41)   31.91  (5.76)   31.55  (5.46) 
[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)
 8.18  (1.03)   8.13  (0.98)   8.10  (0.95)   8.14  (0.99) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 9.13  (6.22)   9.28  (5.93)   8.87  (5.98)   9.10  (6.04) 
Fasting Serum Glucose 
[Units: Millimoles per liter (mmol/L)]
Mean (Standard Deviation)
 9.16  (2.73)   8.96  (2.70)   9.08  (2.66)   9.07  (2.69) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, 52 weeks ]

2.  Secondary:   Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, 26 weeks, and 78 weeks ]

3.  Secondary:   Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks   [ Time Frame: 26, 52, and 78 weeks ]

4.  Secondary:   Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks   [ Time Frame: 26, 52, and 78 weeks ]

5.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

6.  Secondary:   Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)   [ Time Frame: Baseline, 52, and 78 weeks ]

7.  Secondary:   Change From Baseline to 52 and 78 Weeks in Glucagon Concentration   [ Time Frame: Baseline, 52, and 78 weeks ]

8.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks for Body Weight   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

9.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

10.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

11.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

12.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

13.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

14.  Secondary:   Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks   [ Time Frame: 26, 52, and 78 weeks ]

15.  Secondary:   Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks   [ Time Frame: Baseline through 26, 52, and 78 weeks ]

16.  Secondary:   Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks   [ Time Frame: Baseline through 26, 52, and 78 weeks ]

17.  Secondary:   Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks   [ Time Frame: 26, 52, and 78 weeks ]

18.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

19.  Secondary:   Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks   [ Time Frame: Baseline through 26, 52, and 78 weeks ]

20.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

21.  Secondary:   Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks   [ Time Frame: Baseline through 26, 52, and 78 weeks ]

22.  Secondary:   Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

23.  Secondary:   Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

24.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

25.  Secondary:   Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval   [ Time Frame: Baseline, 26, 52, and 78 weeks ]

26.  Secondary:   Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)   [ Time Frame: Baseline, 26, 52, 78, and 83 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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: NCT01075282     History of Changes
Other Study ID Numbers: 11374
H9X-MC-GBDB ( Other Identifier: Eli Lilly and Company )
Study First Received: February 23, 2010
Results First Received: October 3, 2014
Last Updated: January 15, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Canada: Health Canada
United States: Food and Drug Administration
India: Ministry of Health
Mexico: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency