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A Study in Participants With Type I Diabetes Mellitus (IMAGINE 3)

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ClinicalTrials.gov Identifier: NCT01454284
Recruitment Status : Completed
First Posted : October 18, 2011
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
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 1
Interventions: Drug: Glargine
Drug: LY2605541
Drug: Insulin Lispro

  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
LY2605541 + Insulin Lispro

Includes participants randomized to receive LY2605541 plus Insulin Lispro.

Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 52 weeks.

Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks.

Insulin Glargine + Insulin Lispro

Includes participants randomized to receive Insulin Glargine plus Insulin Lispro.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.

Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks.


Participant Flow:   Overall Study
    LY2605541 + Insulin Lispro   Insulin Glargine + Insulin Lispro
STARTED   664   450 
Received at Least 1 Dose of Study Drug   663   449 
COMPLETED   548   377 
NOT COMPLETED   116   73 
Adverse Event                20                7 
Death                0                3 
Lost to Follow-up                13                8 
Protocol Violation                9                6 
Withdrawal by Subject                58                36 
Physician Decision                16                11 
Sponsor Decision                0                2 



  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.

Reporting Groups
  Description
LY2605541 + Insulin Lispro

Participant-specific dose of LY2605541 was administered SC once daily at bedtime for 52 weeks.

Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks.

Insulin Glargine + Insulin Lispro

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 52 weeks.

Participant-specific dose of Insulin Lispro was administered SC at meal times for 52 weeks.

Total Total of all reporting groups

Baseline Measures
   LY2605541 + Insulin Lispro   Insulin Glargine + Insulin Lispro   Total 
Overall Participants Analyzed 
[Units: Participants]
 664   450   1114 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.58  (13.50)   42.28  (13.16)   41.86  (13.36) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   267   169   436 
Male   397   281   678 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   23   18   41 
Not Hispanic or Latino   477   315   792 
Unknown or Not Reported   164   117   281 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   2   2   4 
Asian   6   2   8 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   15   14   29 
White   625   426   1051 
More than one race   15   6   21 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   343   229   572 
Slovakia   5   5   10 
Greece   15   8   23 
Spain   44   30   74 
Ireland   2   3   5 
Lithuania   2   5   7 
Israel   13   9   22 
United Kingdom   38   25   63 
France   12   7   19 
Canada   33   19   52 
Belgium   20   16   36 
Brazil   19   11   30 
Poland   51   33   84 
Croatia   5   5   10 
Denmark   0   1   1 
Australia   22   17   39 
South Africa   16   8   24 
Netherlands   2   1   3 
New Zealand   9   5   14 
Sweden   13   13   26 


  Outcome Measures

1.  Primary:   Hemoglobin A1c (HbA1c)   [ Time Frame: 52 weeks ]

2.  Secondary:   Hemoglobin A1c (HbA1c)   [ Time Frame: 26 weeks ]

3.  Secondary:   Change From Baseline to 52 Weeks in HbA1c   [ Time Frame: Baseline, 52 weeks ]

4.  Secondary:   Total Hypoglycemia Events   [ Time Frame: Baseline through 26 weeks, Baseline through 52 weeks ]

5.  Secondary:   Percentage of Participants With Total Hypoglycemic Events   [ Time Frame: Baseline through 26 weeks, Baseline through 52 weeks ]

6.  Secondary:   Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0%   [ Time Frame: up to 26 weeks, up to 52 weeks ]

7.  Secondary:   Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia   [ Time Frame: up to 26 weeks, up to 52 weeks ]

8.  Secondary:   Nocturnal Hypoglycemia Rates   [ Time Frame: Baseline through 26 weeks, Baseline through 52 weeks ]

9.  Secondary:   Percentage of Participants With Nocturnal Hypoglycemic Events   [ Time Frame: Baseline through 26 weeks, Baseline through 52 weeks ]

10.  Secondary:   Change in Body Weight   [ Time Frame: Baseline, 26 weeks, 52 weeks ]

11.  Secondary:   9 Point Self-monitored Blood Glucose (SMBG)   [ Time Frame: 26 weeks and 52 weeks ]

12.  Secondary:   Fasting Serum Glucose (by Laboratory Measurement)   [ Time Frame: 26 weeks and 52 weeks ]

13.  Secondary:   Fasting Blood Glucose (by Participant Self Monitored Blood Glucose Readings)   [ Time Frame: 26 weeks and 52 weeks ]

14.  Secondary:   Intra-participant Variability of Fasting Blood Glucose (FBG)   [ Time Frame: 26 weeks and 52 weeks ]

15.  Secondary:   0300 Hours Blood Glucose (BG) to Fasting BG Excursion   [ Time Frame: 26 weeks and 52 weeks ]

16.  Secondary:   Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol   [ Time Frame: 26 weeks and 52 weeks ]

17.  Secondary:   Percentage of Participants With Change in Anti-LY2605541 Antibodies   [ Time Frame: 26 weeks, 52 weeks ]

18.  Secondary:   Basal, Meal Time, and Total Insulin Dose Per Body Weight   [ Time Frame: 26 weeks and 52 weeks ]

19.  Secondary:   Insulin Treatment Satisfaction Questionnaire   [ Time Frame: up to 52 weeks ]

20.  Secondary:   European Quality of Life -5 Dimension (EQ-5D-3L)   [ Time Frame: up to 52 weeks ]

21.  Secondary:   Adult Low Blood Sugar Survey   [ Time Frame: 26 weeks and 52 weeks ]

22.  Secondary:   Rapid Assessment of Physical Activity (RAPA)   [ Time Frame: 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: NCT01454284     History of Changes
Other Study ID Numbers: 12147
I2R-MC-BIAO ( Other Identifier: Eli Lilly and Company )
2011-001253-82 ( EudraCT Number )
First Submitted: October 14, 2011
First Posted: October 18, 2011
Results First Submitted: March 16, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018