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A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus (IMAGINE 5)

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ClinicalTrials.gov Identifier: NCT01582451
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : April 20, 2018
Last Update Posted : April 20, 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 2
Interventions: Drug: LY2605541
Drug: Insulin glargine

  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 LY2605541 was administered by subcutaneous (SQ) injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG).
Insulin Glargine Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.

Participant Flow:   Overall Study
    LY2605541   Insulin Glargine
STARTED   307   159 
Received at Least 1 Dose of Study Drug   305   159 
COMPLETED   275   139 
NOT COMPLETED   32   20 
Adverse Event                1                3 
Death                3                3 
Lost to Follow-up                0                2 
Protocol Violation                11                3 
Withdrawal by Subject                13                9 
Physician Decision                3                0 
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 randomized participants.

Reporting Groups
  Description
LY2605541 LY2605541 was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
Insulin Glargine Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
Total Total of all reporting groups

Baseline Measures
   LY2605541   Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 307   159   466 
Age 
[Units: Years]
Mean (Standard Deviation) 		 61.84  (8.52)   60.38  (10.10)   61.34  (9.11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female   132   66   198 
Male   175   93   268 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
Hispanic or Latino   57   25   82 
Not Hispanic or Latino   215   115   330 
Unknown or Not Reported   35   19   54 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
American Indian or Alaska Native   2   0   2 
Asian   4   2   6 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   17   9   26 
White   280   148   428 
More than one race   1   0   1 
Unknown or Not Reported   2   0   2 
Region of Enrollment 
[Units: Participants]
Count of Participants 		     
United States   170   85   255 
Czechia   20   10   30 
Greece   16   5   21 
Spain   27   12   39 
Romania   16   14   30 
Israel   16   8   24 
Russia   17   9   26 
Germany   25   16   41 


  Outcome Measures

1.  Primary:   Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 26 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline to 52 Weeks in HbA1c   [ Time Frame: Baseline, 52 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events   [ Time Frame: Baseline through 26 weeks and Baseline through 52 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Fasting Serum Glucose (FSG) (by Laboratory)   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Fasting Blood Glucose (FBG) (by Self Monitoring)   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Intra-participant Variability in Fasting Blood Glucose (FBG)   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 9

10.  Secondary:   6-point Self-monitored Blood Glucose (SMBG)   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 10

11.  Secondary:   HbA1c   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Insulin Dose Per Kilogram of Body Weight   [ Time Frame: 26 and 52 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Number of Insulin Dose Adjustments to Steady-state   [ Time Frame: Baseline through 26 weeks ]
  Show Outcome Measure 13

14.  Secondary:   European Quality of Life - 5 Dimension (EuroQol-5D) Score   [ Time Frame: 26 weeks ]
  Show Outcome Measure 14

15.  Secondary:   Insulin Treatment Satisfaction Questionnaire (ITSQ) Score   [ Time Frame: 26 weeks ]
  Show Outcome Measure 15

16.  Secondary:   Adult Low Blood Sugar Survey (LBSS) Score   [ Time Frame: 26 weeks ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, 26 weeks, 52 weeks ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in Lipid Profile   [ Time Frame: Baseline, 26 weeks, 52 weeks ]
  Show Outcome Measure 18

19.  Secondary:   Number of Participants With Change in Anti-LY2605541 Antibodies   [ Time Frame: Baseline through 52 weeks ]
  Show Outcome Measure 19


  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: NCT01582451     History of Changes
Other Study ID Numbers: 14703
I2R-MC-BIDJ ( Other Identifier: Eli Lilly and Company )
First Submitted: April 19, 2012
First Posted: April 20, 2012
Results First Submitted: March 17, 2018
Results First Posted: April 20, 2018
Last Update Posted: April 20, 2018