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A Study in Adults With Type 1 Diabetes (ELEMENT 1)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01421147
First received: August 19, 2011
Last updated: October 3, 2014
Last verified: October 2014
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 1
Interventions: Drug: LY2963016
Drug: Lantus
Drug: Insulin Lispro

  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
This study included a 24-week treatment period followed by a 28-week extension period.

Reporting Groups
  Description
LY2963016 + Insulin Lispro LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus + Insulin Lispro Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.

Participant Flow for 2 periods

Period 1:   Treatment Period
    LY2963016 + Insulin Lispro   Lantus + Insulin Lispro
STARTED   269   267 
Received at Least 1 Dose of Study Drug   268   267 
COMPLETED   253   256 
NOT COMPLETED   16   11 
Adverse Event                2                3 
Lost to Follow-up                2                1 
Physician Decision                2                2 
Withdrawal by Subject                10                5 

Period 2:   Extension Period
    LY2963016 + Insulin Lispro   Lantus + Insulin Lispro
STARTED   253   256 
COMPLETED   245   245 
NOT COMPLETED   8   11 
Adverse Event                0                2 
Death                0                1 
Lost to Follow-up                2                5 
Physician Decision                1                0 
Withdrawal by Subject                5                3 



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

Reporting Groups
  Description
LY2963016 + Insulin Lispro LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Lantus + Insulin Lispro Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
Total Total of all reporting groups

Baseline Measures
   LY2963016 + Insulin Lispro   Lantus + Insulin Lispro   Total 
Overall Participants Analyzed 
[Units: Participants]
 268   267   535 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.96  (13.65)   41.37  (13.25)   41.16  (13.44) 
Gender 
[Units: Participants]
     
Female   113   112   225 
Male   155   155   310 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   11   10   21 
Not Hispanic or Latino   177   170   347 
Unknown or Not Reported   80   87   167 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   11   12   23 
Asian   49   51   100 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   9   2   11 
White   197   201   398 
More than one race   1   1   2 
Unknown or Not Reported   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   99   96   195 
Hungary   14   16   30 
Mexico   17   19   36 
Greece   15   13   28 
Belgium   12   11   23 
Poland   18   17   35 
Romania   18   16   34 
Germany   26   28   54 
Japan   49   51   100 
Baseline Hemoglobin A1c (HbA1c) [1] 
[Units: Percentage of glycosylated hemoglobin]
Mean (Standard Deviation)
 7.75  (1.13)   7.79  (1.03)   7.77  (1.08) 
[1] HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period.
Time of Basal Insulin Injection [1] 
[Units: Participants]
     
Daytime   51   48   99 
Evening/Bedtime   217   219   436 
[1] Number of participants who administered a basal insulin injection during the Daytime and Evening/Bedtime.
Body Weight 
[Units: Kilograms (kg)]
Mean (Standard Deviation)
 75.80  (16.76)   74.77  (15.36)   75.29  (16.07) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, Endpoint (up to 24 weeks) ]

2.  Secondary:   Change From Baseline in Insulin Antibody Levels   [ Time Frame: Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks) ]

3.  Secondary:   Change From Baseline in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks) ]

4.  Secondary:   7-Point Self-Monitored Blood Glucose (SMBG) Profiles   [ Time Frame: Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks] ]

5.  Secondary:   Glycemic Variability of Fasting Blood Glucose   [ Time Frame: Baseline and Endpoints (up to 24 weeks and up 52 weeks) ]

6.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks) ]

7.  Secondary:   Adult Low Blood Sugar Survey (ALBSS)   [ Time Frame: Baseline and 24 weeks and Endpoint (up to 52 weeks) ]

8.  Secondary:   Insulin Treatment Satisfaction Questionnaire (ITSQ)   [ Time Frame: Baseline and 24 weeks and Endpoint (up to 52 weeks) ]

9.  Secondary:   Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])   [ Time Frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks] ]

10.  Secondary:   Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])   [ Time Frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks] ]

11.  Secondary:   Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%   [ Time Frame: Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks) ]

12.  Secondary:   Incidence of Hypoglycemic Events   [ Time Frame: Baseline through 24 weeks (wk) and 52 weeks ]

13.  Secondary:   Rate Per 30 Days of Hypoglycemic Events   [ Time Frame: Baseline through 24 weeks (wk) and 52 weeks ]


  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
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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: NCT01421147     History of Changes
Other Study ID Numbers: 13712
I4L-MC-ABEB ( Other Identifier: Eli Lilly and Company )
2011-000829-73 ( EudraCT Number )
Study First Received: August 19, 2011
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Protection Against Health Risks
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation