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Trial record 16 of 39 for:    LY2189265

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01126580
Recruitment Status : Completed
First Posted : May 19, 2010
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Metformin
Drug: LY2189265
Drug: Placebo (oral)
Drug: Placebo (subcutaneous)

  Participant Flow

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), subcutaneously (SC), once weekly for 52 weeks

Placebo: orally, twice daily for 52 weeks

0.75 mg LY2189265

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

Placebo: orally, twice daily for 52 weeks

Metformin

Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks

Placebo: subcutaneously (SC), once weekly for 52 weeks


Participant Flow:   Overall Study
    1.5 mg LY2189265   0.75 mg LY2189265   Metformin
STARTED   269   270   268 
Received at Least 1 Dose of Study Drug   269   270   268 
Completed 26 Weeks   233   242   226 
COMPLETED   220   218   213 
NOT COMPLETED   49   52   55 
Adverse Event                14                8                12 
Withdrawal by Subject                11                19                14 
Sponsor Decision                5                4                7 
Physician Decision                1                1                2 
Entry Criteria Not Met                1                1                2 
Lack of Efficacy                2                3                4 
Protocol Violation                0                1                2 
Lost to Follow-up                15                13                9 
Treatment Non-compliance                0                2                3 



  Baseline Characteristics

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 received at least 1 dose of LY2189265 or Metformin.

Reporting Groups
  Description
1.5 mg LY2189265

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

Placebo: orally, twice daily for 52 weeks

0.75 mg LY2189265

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

Placebo: orally, twice daily for 52 weeks

Metformin

Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks

Placebo: subcutaneously (SC), once weekly for 52 weeks

Total Total of all reporting groups

Baseline Measures
   1.5 mg LY2189265   0.75 mg LY2189265   Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 269   270   268   807 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.51  (10.38)   55.90  (10.68)   55.26  (10.10)   55.56  (10.38) 
Gender 
[Units: Participants]
       
Female   155   152   147   454 
Male   114   118   121   353 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   90   87   95   272 
Not Hispanic or Latino   179   183   173   535 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   29   28   28   85 
Asian   21   20   20   61 
Native Hawaiian or Other Pacific Islander   0   0   1   1 
Black or African American   17   22   14   53 
White   201   198   201   600 
More than one race   1   2   4   7 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   77   80   74   231 
Slovakia   8   9   9   26 
Finland   3   5   4   12 
Spain   12   11   12   35 
United Kingdom   0   1   1   2 
India   9   11   9   29 
France   12   12   13   37 
Czech Republic   10   9   8   27 
Mexico   24   25   23   72 
Canada   10   9   11   30 
Puerto Rico   14   10   15   39 
Argentina   27   27   26   80 
Poland   7   6   5   18 
Brazil   2   2   3   7 
Croatia   3   4   4   11 
Romania   14   13   13   40 
South Africa   12   11   12   35 
Germany   22   21   21   64 
Korea, Republic of   3   4   5   12 
Body Weight 
[Units: Kilograms (kg)]
Mean (Standard Deviation)
 92.67  (18.79)   91.79  (18.67)   92.40  (19.23)   92.28  (18.87) 
Body Mass Index (BMI) [1] 
[Units: Kilograms per square meter (kg/m^2)]
Mean (Standard Deviation)
 33.66  (5.65)   33.08  (5.84)   33.05  (5.06)   33.26  (5.53) 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 2.65  (1.50)   2.60  (2.17)   2.63  (1.77)   2.63  (1.83) 
Glycosylated Hemoglobin (HbA1c) 
[Units: Percentage of glycosylated hemoglobin]
Mean (Standard Deviation)
 7.63  (0.92)   7.58  (0.87)   7.60  (0.82)   7.60  (0.87) 


  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 Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks   [ Time Frame: 26 weeks and 52 weeks ]

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

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

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

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

8.  Secondary:   Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

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

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

11.  Secondary:   Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

12.  Secondary:   Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version   [ Time Frame: 52 weeks ]

13.  Secondary:   Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

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

15.  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 ]

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

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

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

19.  Secondary:   Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

20.  Secondary:   Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

21.  Secondary:   Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

22.  Secondary:   Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides   [ Time Frame: Baseline, 26 weeks, and 52 weeks ]

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

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

25.  Secondary:   Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies   [ Time Frame: Baseline through 52 weeks ]

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

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

28.  Secondary:   Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up   [ Time Frame: Baseline through 52 weeks plus 30-day follow up ]

29.  Secondary:   Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up   [ Time Frame: Baseline through 52 weeks plus 30-day follow up ]

30.  Secondary:   Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)   [ Time Frame: 4 weeks, 13 weeks, 26 weeks, and 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: NCT01126580     History of Changes
Other Study ID Numbers: 11375
H9X-MC-GBDC ( Other Identifier: Eli Lilly and Company )
CTRI/2010/091/003036 ( Registry Identifier: Clinical Trials Register India )
First Submitted: May 18, 2010
First Posted: May 19, 2010
Results First Submitted: October 3, 2014
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015