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A Study in Participants With Type 2 Diabetes Mellitus (IMAGINE 4)

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ClinicalTrials.gov Identifier: NCT01468987
Recruitment Status : Completed
First Posted : November 10, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: LY2605541
Drug: Insulin Glargine
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 that were randomized to receive LY2605541 plus Insulin Lispro.

Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

Insulin Glargine + Insulin Lispro

Includes participants that were randomized to receive Insulin Glargine plus Insulin Lispro.

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.


Participant Flow:   Overall Study
    LY2605541 + Insulin Lispro   Insulin Glargine + Insulin Lispro
STARTED   691   678 
Received at Least 1 Dose of Study Drug   691   677 
COMPLETED   620   618 
NOT COMPLETED   71   60 
Adverse Event                12                9 
Death                4                1 
Lost to Follow-up                10                5 
Protocol Violation                8                2 
Withdrawal by Subject                28                28 
Physician Decision                8                15 
Sponsor Decision                1                0 



  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 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Insulin Glargine + Insulin Lispro

Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

Total Total of all reporting groups

Baseline Measures
   LY2605541 + Insulin Lispro   Insulin Glargine + Insulin Lispro   Total 
Overall Participants Analyzed 
[Units: Participants]
 691   678   1369 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.43  (9.21)   57.77  (9.17)   57.6  (9.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   315   274   589 
Male   376   404   780 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   74   78   152 
Not Hispanic or Latino   452   427   879 
Unknown or Not Reported   165   173   338 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   2   2   4 
Asian   25   30   55 
Native Hawaiian or Other Pacific Islander   2   2   4 
Black or African American   42   50   92 
White   615   585   1200 
More than one race   5   9   14 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   276   270   546 
Taiwan   7   8   15 
Slovakia   25   17   42 
Greece   12   11   23 
Spain   30   35   65 
Lithuania   4   2   6 
Turkey   4   7   11 
Austria   9   6   15 
Russia   19   20   39 
Israel   20   20   40 
United Kingdom   5   3   8 
Italy   16   16   32 
Czechia   23   22   45 
Hungary   36   36   72 
Mexico   13   12   25 
Puerto Rico   20   26   46 
Poland   20   20   40 
Brazil   11   13   24 
Romania   34   31   65 
Croatia   5   2   7 
Denmark   9   3   12 
Australia   26   25   51 
Netherlands   7   8   15 
Germany   50   54   104 
Japan   10   11   21 


  Outcome Measures

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

2.  Secondary:   Total Hypoglycemia Rates (Adjusted for 30 Days)   [ Time Frame: Baseline through 26 weeks ]

3.  Secondary:   Percentage of Participants With Total Hypoglycemia Episodes   [ Time Frame: Baseline through 26 weeks ]

4.  Secondary:   Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)   [ Time Frame: Baseline through 26 weeks ]

5.  Secondary:   Percentage of Participants With Nocturnal Hypoglycemia Episodes   [ Time Frame: Baseline through 26 weeks ]

6.  Secondary:   Body Weight Change From Baseline to 26 Weeks   [ Time Frame: Baseline, 26 weeks ]

7.  Secondary:   Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks   [ Time Frame: 26 weeks ]

8.  Secondary:   Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks   [ Time Frame: up to 26 weeks ]

9.  Secondary:   Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks   [ Time Frame: up to 26 weeks ]

10.  Secondary:   Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks   [ Time Frame: 26 weeks ]

11.  Secondary:   Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks   [ Time Frame: 26 weeks ]

12.  Secondary:   Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks   [ Time Frame: 26 weeks ]

13.  Secondary:   0300-hour Blood Glucose to FBG Excursion at 26 Weeks   [ Time Frame: 26 weeks ]

14.  Secondary:   HbA1c at 26 Weeks   [ Time Frame: 26 weeks ]

15.  Secondary:   Lipid Profile at 26 Weeks   [ Time Frame: 26 weeks ]

16.  Secondary:   Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks   [ Time Frame: Baseline through 26 weeks ]

17.  Secondary:   Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks   [ Time Frame: up to 26 weeks ]

18.  Secondary:   Low Blood Sugar Survey (LBSS) at 26 Weeks   [ Time Frame: 26 weeks ]

19.  Secondary:   EuroQoL-5D (EQ-5D) at 26 Weeks   [ Time Frame: up to 26 weeks ]

20.  Secondary:   Rapid Assessment of Physical Activity (RAPA) at 26 Weeks   [ Time Frame: up to 26 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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01468987     History of Changes
Other Study ID Numbers: 12145
I2R-MC-BIAM ( Other Identifier: Eli Lilly and Company )
2011-001254-29 ( EudraCT Number )
First Submitted: November 8, 2011
First Posted: November 10, 2011
Results First Submitted: March 16, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018