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A Study in Participants With Diabetic Kidney Disease

This study has been terminated.
(Interim Assessment: Lack of Efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113801
First Posted: April 30, 2010
Last Update Posted: December 13, 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: September 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Diabetic Kidney Disease
Diabetic Nephropathy
Diabetic Glomerulosclerosis
Interventions: Drug: LY2382770
Drug: Placebo

  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
Placebo Placebo given subcutaneous (SC) injection monthly for 12 months
2 mg LY2382770 2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
10 mg LY2382770 10 mg LY2382770 given SC injection monthly for 12 months
50 mg LY2382770 50 mg LY2382770 given SC injection monthly for 12 months

Participant Flow:   Overall Study
    Placebo   2 mg LY2382770   10 mg LY2382770   50 mg LY2382770
STARTED   103   105   103   106 
Received at Least One Dose of Drug   103   105   103   105 
COMPLETED   62   65   66   65 
NOT COMPLETED   41   40   37   41 
Adverse Event                4                0                2                6 
Death                4                5                3                4 
Protocol Violation                0                1                0                0 
Withdrawal by Subject                9                7                7                8 
Physician Decision                2                2                3                3 
Sponsor Decision                15                21                20                15 
Clinical Endpoint (ESRD)                7                4                2                5 



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

Reporting Groups
  Description
Placebo Placebo given subcutaneous (SC) injection monthly for 12 months
2 mg LY2382770 2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
10 mg LY2382770 10 mg LY2382770 given SC injection monthly for 12 months
50 mg LY2382770 50 mg LY2382770 given SC injection monthly for 12 months
Total Total of all reporting groups

Baseline Measures
   Placebo   2 mg LY2382770   10 mg LY2382770   50 mg LY2382770   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   105   103   105   416 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.7  (11.31)   62.8  (9.20)   60.5  (9.05)   62.9  (10.86)   62.2  (10.16) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female   27   21   29   19   96 
Male   76   84   74   86   320 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino   8   11   11   15   45 
Not Hispanic or Latino   55   58   53   45   211 
Unknown or Not Reported   40   36   39   45   160 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   4   2   2   8 
Native Hawaiian or Other Pacific Islander   1   0   1   0   2 
Black or African American   14   9   9   7   39 
White   83   90   84   90   347 
More than one race   1   0   2   0   3 
Unknown or Not Reported   4   2   5   6   17 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
France   8   9   7   8   32 
United States   37   35   38   36   146 
Czechia   14   9   10   12   45 
Hungary   11   16   15   15   57 
Puerto Rico   3   5   2   5   15 
Australia   10   10   10   10   40 
Israel   20   21   21   20   82 
Serum Creatinine 
[Units: Milligram/deciliter (mg/dl)]
Mean (Standard Deviation)
 2.209  (0.5917)   2.127  (0.5824)   2.091  (0.6538)   2.132  (0.6289)   2.140  (0.6141) 
Urine Protein/Creatinine Ratio 
[Units: Gram/gram]
Mean (Standard Deviation)
 3.123  (2.5180)   3.266  (2.5723)   3.301  (2.4510)   3.354  (2.5457)   3.262  (2.5148) 
Estimated Glomerular Filtration Rate (eGFR) 
[Units: Milliliter/minute/1.73 meter squared]
Mean (Standard Deviation)
 33.835  (11.0568)   35.705  (11.7226)   36.358  (12.5154)   35.945  (12.0852)   35.464  (11.8539) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint   [ Time Frame: Baseline, 12 months ]

2.  Secondary:   Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint   [ Time Frame: Baseline, 12 months ]

3.  Secondary:   Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration –Time Curve (AUC ) Over a Dosing Interval   [ Time Frame: Baseline through 12 months (samples collected pre and/or postdose at monthly intervals) ]

4.  Secondary:   Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months   [ Time Frame: Baseline through 12 months ]

5.  Secondary:   Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months   [ Time Frame: Baseline through 12 months ]


  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
Study was stopped early for efficacy futility per recommendation by the independent Data Safety Monitoring Committee.


  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: NCT01113801     History of Changes
Other Study ID Numbers: 10168
H9V-MC-GFRF ( Other Identifier: Eli Lilly and Company )
First Submitted: April 28, 2010
First Posted: April 30, 2010
Results First Submitted: September 27, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017