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A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) (AWARD-7)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621178
First Posted: June 18, 2012
Last Update Posted: July 24, 2017
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.
Information provided by (Responsible Party):
Eli Lilly and Company
Results First Submitted: June 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
Chronic Kidney Disease
Interventions: Drug: Dulaglutide
Drug: Insulin glargine
Drug: Insulin lispro

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Treatment period is up to 26 week and extended treatment period will be up to 52 weeks. Data after 26 weeks will be available after 1-year after last patient visit (LPV).

Reporting Groups
  Description
Insulin Glargine Insulin glargine was administered subcutaneously (SQ) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
0.75 mg Dulaglutide 0.75 milligram (mg) of dulaglutide was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
1.5 mg Dulaglutide 1.5 mg of dulaglutide was administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.

Participant Flow:   Overall Study
    Insulin Glargine   0.75 mg Dulaglutide   1.5 mg Dulaglutide
STARTED   194   190   193 
Received at Least One Dose of Study Drug   194   190   192 
COMPLETED   179   168   162 
NOT COMPLETED   15   22   31 
Adverse Event                1                1                7 
Death                2                4                1 
Lost to Follow-up                1                1                1 
Withdrawal by Subject                8                14                17 
Physician Decision                3                2                5 



  Baseline Characteristics
  Hide 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 one dose of study drug and had evaluable post-baseline measurements.

Reporting Groups
  Description
Insulin Glargine Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
Dulaglutide 0.75 mg Dulaglutide 0.75 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
Dulaglutide 1.5 mg Dulaglutide 1.5 mg administered once weekly as a SQ injection. Participants were instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
Total Total of all reporting groups

Baseline Measures
   Insulin Glargine   Dulaglutide 0.75 mg   Dulaglutide 1.5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 194   190   192   576 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (8.41)   64.7  (8.61)   64.7  (8.83)   64.6  (8.60) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female   101   86   88   275 
Male   93   104   104   301 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino   79   75   78   232 
Not Hispanic or Latino   115   115   114   344 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native   18   17   12   47 
Asian   5   4   7   16 
Native Hawaiian or Other Pacific Islander   1   0   0   1 
Black or African American   26   36   26   88 
White   137   122   134   393 
More than one race   6   7   10   23 
Unknown or Not Reported   1   4   3   8 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Romania   14   9   14   37 
Hungary   22   19   14   55 
United States   61   59   62   182 
Ukraine   17   11   12   40 
Brazil   44   47   50   141 
Poland   1   2   2   5 
Mexico   19   19   15   53 
South Africa   14   20   17   51 
Spain   2   4   6   12 
Body Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 88.20  (18.488)   90.88  (18.301)   88.14  (16.015)   89.06  (17.653) 
Body Mass Index (BMI) 
[Units: Kilogram/square meter (kg/m^2)]
Mean (Standard Deviation)
 32.39  (5.324)   33.00  (5.546)   32.11  (4.841)   32.50  (5.248) 
Hemoglobin A1C (HbA1c) at Baseline 
[Units: Percentage of HbA1c]
Mean (Standard Deviation)
 8.56  (0.966)   8.57  (1.088)   8.59  (0.860)   8.57  (0.973) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 18.71  (8.742)   17.95  (8.788)   17.57  (8.722)   18.08  (8.748) 
Duration of Chronic Kidney Disease (CKD) Stage 3 or Higher 
[Units: Years]
Mean (Standard Deviation)
 3.47  (3.998)   4.03  (4.854)   4.18  (5.632)   3.89  (4.872) 
Estimated Glomerular Filtration Rate (eGFR) 
[Units: Milliliter/minute/1.73 square meter]
Mean (Standard Deviation)
 38.5  (12.99)   38.3  (12.31)   38.1  (13.24)   38.3  (12.83) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 26 Weeks ]

2.  Secondary:   Percentage of Participants Whose HbA1c Was <7.0%   [ Time Frame: 26 Weeks ]

3.  Secondary:   Percentage of Participants Whose HbA1c Was <8.0%   [ Time Frame: 26 Weeks ]

4.  Secondary:   Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)   [ Time Frame: Baseline, 26 Weeks ]

5.  Secondary:   Change From Baseline in Fasting Glucose (FG)   [ Time Frame: Baseline, 26 Weeks ]

6.  Secondary:   Change From Baseline in Mean Daily Insulin Lispro Dose   [ Time Frame: 26 Weeks ]

7.  Secondary:   Percentage of Participants With Estimated Average Glucose <154 mg/dL   [ Time Frame: 26 Weeks ]

8.  Secondary:   Change From Baseline in Serum Creatinine (sCr)   [ Time Frame: Baseline, 26 Weeks ]

9.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)   [ Time Frame: Baseline, 26 Weeks ]

10.  Secondary:   Change From Baseline in Estimated Creatinine Clearance (eCrCl)   [ Time Frame: Baseline, 26 Weeks ]

11.  Secondary:   Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)   [ Time Frame: Baseline, 26 Weeks ]

12.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, 26 Weeks ]

13.  Secondary:   Percentage of Participants With Self-Reported Hypoglycemic Events (HE)   [ Time Frame: Baseline through 26 Weeks ]

14.  Secondary:   Rate of Hypoglycemic Events   [ Time Frame: Baseline through 26 Weeks ]

15.  Secondary:   Change From Baseline in HbA1c   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

16.  Secondary:   Percentage of Participants Whose HbA1c is <7.0%   [ Time Frame: 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

17.  Secondary:   Percentage of Participants Whose HbA1c is <8.0%   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

18.  Secondary:   Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

19.  Secondary:   Change From Baseline in Fasting Glucose   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

20.  Secondary:   Change in Mean Daily Insulin Lispro Dose   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

21.  Secondary:   Percentage of Participants With Estimated Average Glucose <154 mg/dL   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

22.  Secondary:   Change From Baseline in Serum Creatinine (sCr)   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

23.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

24.  Secondary:   Change From Baseline in Estimated Creatinine Clearance (eCrCl)   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

25.  Secondary:   Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

26.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

27.  Secondary:   Percentage of Participants With Self-Reported HE   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

28.  Secondary:   Rate of HE   [ Time Frame: Baseline, 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

29.  Secondary:   Percentage of Participants With Allergic/Hypersensitivity Reactions   [ Time Frame: Baseline through 52 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  


  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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01621178     History of Changes
Other Study ID Numbers: 13798
H9X-MC-GBDX ( Other Identifier: Eli Lilly and Company )
2012-000829-44 ( EudraCT Number )
First Submitted: June 14, 2012
First Posted: June 18, 2012
Results First Submitted: June 21, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017



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