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A Study in Participants With Type 1 Diabetes Mellitus (IMAGINE 1)

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ClinicalTrials.gov Identifier: NCT01481779
Recruitment Status : Completed
First Posted : November 30, 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: None (Open Label);   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 LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine + Insulin Lispro Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

Participant Flow:   Overall Study
    LY2605541 + Insulin Lispro   Glargine + Insulin Lispro
STARTED   295   160 
Received at Least 1 Dose of Study Drug   294   159 
COMPLETED   225   132 
NOT COMPLETED   70   28 
Adverse Event                23                5 
Lost to Follow-up                3                2 
Protocol Violation                2                3 
Withdrawal by Subject                26                13 
Physician Decision                13                4 
Sponsor Decision                3                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 randomized participants.

Reporting Groups
  Description
LY2605541 + Insulin Lispro LY2605541 titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Glargine + Insulin Lispro Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Total Total of all reporting groups

Baseline Measures
   LY2605541 + Insulin Lispro   Glargine + Insulin Lispro   Total 
Overall Participants Analyzed 
[Units: Participants]
 295   160   455 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.68  (12.93)   38.91  (14.10)   39.41  (13.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   157   73   230 
Male   138   87   225 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   33   16   49 
Not Hispanic or Latino   153   85   238 
Unknown or Not Reported   109   59   168 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   6   3   9 
Asian   63   31   94 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   0   5 
White   221   125   346 
More than one race   0   1   1 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
France   23   14   37 
United States   85   45   130 
Mexico   25   15   40 
Poland   27   14   41 
Austria   7   4   11 
Russia   11   9   20 
Germany   45   21   66 
Japan   60   31   91 
Italy   12   7   19 


  Outcome Measures

1.  Primary:   Hemoglobin A1c (HbA1c) at 26 Weeks   [ Time Frame: 26 weeks ]

2.  Secondary:   Hemoglobin A1c (HbA1c)   [ Time Frame: 52 weeks and 78 weeks ]

3.  Secondary:   Change From Baseline in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 26 weeks, 52 weeks, 78 weeks ]

4.  Secondary:   Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

5.  Secondary:   Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

6.  Secondary:   Total Hypoglycemia Rates (Adjusted by 30 Days)   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks ]

7.  Secondary:   Percentage of Participants With Total Hypoglycemia Events   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks ]

8.  Secondary:   Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks ]

9.  Secondary:   Percentage of Participants With Nocturnal Hypoglycemic Events   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks ]

10.  Secondary:   Fasting Serum Glucose (FSG) by Laboratory Measurement   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

11.  Secondary:   Fasting Blood Glucose (FBG) Intra-participant Variability   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

12.  Secondary:   0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

13.  Secondary:   9 Point Self-monitored Blood Glucose (SMBG)   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

14.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline and 26 weeks and 52 weeks and 78 weeks ]

15.  Secondary:   Basal, Bolus, and Total Insulin Dose   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

16.  Secondary:   Lipid Profile   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

17.  Secondary:   Percentage of Participants With Change in Anti-LY2605541 Antibodies   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks ]

18.  Secondary:   Insulin Treatment Satisfaction Questionnaire (ITSQ)   [ Time Frame: 26 weeks ]

19.  Secondary:   Low Blood Sugar Survey (LBSS)   [ Time Frame: 26 weeks and 52 weeks and 78 weeks ]

20.  Secondary:   European Quality of Life-5 Dimension (EQ-5D)   [ Time Frame: 26 weeks ]

21.  Secondary:   Rapid Assessment of Physical Activity (RAPA)   [ Time Frame: 26 weeks and 78 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: NCT01481779     History of Changes
Other Study ID Numbers: 12146
I2R-MC-BIAN ( Other Identifier: Eli Lilly and Company )
2011-001261-40 ( EudraCT Number )
First Submitted: November 28, 2011
First Posted: November 30, 2011
Results First Submitted: March 16, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018