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Trial record 26 of 39 for:    LY2189265

A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes (AWARD-9)

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ClinicalTrials.gov Identifier: NCT02152371
Recruitment Status : Completed
First Posted : June 2, 2014
Results First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Dulaglutide
Drug: Placebo
Drug: Insulin Glargine
Drug: Metformin

  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
All eligible participants entered a 2-week lead-in period. Only those participants who required further up-titration of the insulin glargine dose per treat-to-target (TTT) algorithm were randomized to one of two treatment groups.

Reporting Groups
  Description
Dulaglutide + Insulin Glargine 1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo + Insulin Glargine Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.

Participant Flow:   Overall Study
    Dulaglutide + Insulin Glargine   Placebo + Insulin Glargine
STARTED   150   150 
Received at Least 1 Dose of Study Drug.   150   150 
COMPLETED   138   134 
NOT COMPLETED   12   16 
Adverse Event                6                2 
Withdrawal by Subject                3                7 
Protocol Violation                2                3 
Lost to Follow-up                1                0 
Lack of Efficacy                0                1 
Physician Decision                0                2 
Reason Not Given                0                1 



  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.
All participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Dulaglutide + Insulin Glargine 1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo + Insulin Glargine Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Total Total of all reporting groups

Baseline Measures
   Dulaglutide + Insulin Glargine   Placebo + Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   150   300 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (9.47)   60.6  (10.07)   60.4  (9.76) 
Gender 
[Units: Participants]
     
Female   65   62   127 
Male   85   88   173 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   26   25   51 
Not Hispanic or Latino   104   104   208 
Unknown or Not Reported   20   21   41 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   1   2   3 
Black or African American   5   6   11 
White   143   138   281 
More than one race   1   3   4 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Czech Republic   25   27   52 
Puerto Rico   12   16   28 
Hungary   37   35   72 
United States   32   29   61 
Italy   13   15   28 
United Kingdom   2   2   4 
Spain   29   26   55 
Mean Insulin Glargine Dose 
[Units: Units (U)]
Mean (Standard Deviation)
 40.71  (23.12)   36.59  (21.46)   38.65  (22.37) 
Metformin Use at Baseline 
[Units: Participants]
     
Treated with Metformin   134   131   265 
Not Treated with Metformin   16   19   35 


  Outcome Measures

1.  Primary:   Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 28 Weeks ]

2.  Secondary:   Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)   [ Time Frame: Baseline, 28 Weeks ]

3.  Secondary:   Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)   [ Time Frame: Baseline, 28 Weeks ]

4.  Secondary:   Change From Baseline to 28 Weeks in Body Weight   [ Time Frame: Baseline, 28 Weeks ]

5.  Secondary:   Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose   [ Time Frame: Baseline, 28 Weeks ]

6.  Secondary:   Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events   [ Time Frame: Baseline through 28 Weeks ]

7.  Secondary:   Percentage of Participants With Self-Reported Events of Hypoglycemia   [ Time Frame: Baseline through 28 Weeks ]

8.  Secondary:   Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia   [ Time Frame: Baseline through 28 Weeks ]

9.  Secondary:   Number of Participants With Adjudicated Acute Pancreatitis Events   [ Time Frame: Baseline through 28 Weeks ]

10.  Secondary:   Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)   [ Time Frame: Baseline through 28 Weeks ]

11.  Secondary:   Number of Participants With Dulaglutide Anti-Drug Antibodies   [ Time Frame: Baseline, Week 12 and Week 28 ]

12.  Secondary:   Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%   [ Time Frame: 28 Weeks ]

13.  Secondary:   Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)   [ Time Frame: 28 Weeks ]

14.  Secondary:   Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)   [ Time Frame: 28 Weeks ]

15.  Secondary:   Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)   [ Time Frame: 28 Weeks ]

16.  Secondary:   Rate of Hypoglycemic Events up to 28 Weeks   [ Time Frame: Baseline through 28 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: 1-800-545-5979


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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02152371     History of Changes
Other Study ID Numbers: 13195
H9X-MC-GBDI ( Other Identifier: Eli Lilly and Company )
2012-004229-25 ( EudraCT Number )
First Submitted: May 28, 2014
First Posted: June 2, 2014
Results First Submitted: October 12, 2016
Results First Posted: December 7, 2016
Last Update Posted: December 7, 2016