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A Study in Patients With Type 2 Diabetes Mellitus (IMAGINE 2)

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ClinicalTrials.gov Identifier: NCT01435616
Recruitment Status : Completed
First Posted : September 16, 2011
Results First Posted : April 13, 2018
Last Update Posted : April 13, 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 2
Interventions: Drug: Glargine
Drug: LY2605541

  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 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
Glargine Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks

Participant Flow:   Overall Study
    LY2605541   Glargine
STARTED   1003   535 
Received at Least 1 Dose of Study Drug   1003   535 
COMPLETED   832   455 
NOT COMPLETED   171   80 
Adverse Event                39                21 
Death                7                2 
Lost to Follow-up                22                13 
Protocol Violation                16                13 
Withdrawal by Subject                66                24 
Physician Decision                20                7 
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 titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
Glargine Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
Total Total of all reporting groups

Baseline Measures
   LY2605541   Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 1003   535   1538 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.80  (9.85)   59.35  (9.80)   58.99  (9.84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   453   227   680 
Male   550   308   858 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   201   96   297 
Not Hispanic or Latino   648   355   1003 
Unknown or Not Reported   154   84   238 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   24   15   39 
Asian   25   12   37 
Native Hawaiian or Other Pacific Islander   3   2   5 
Black or African American   68   34   102 
White   875   469   1344 
More than one race   8   3   11 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   371   188   559 
Slovakia   12   10   22 
Greece   18   12   30 
Finland   6   7   13 
Spain   35   18   53 
Turkey   7   4   11 
Lithuania   8   4   12 
Israel   16   8   24 
Russia   32   18   50 
Italy   24   13   37 
United Kingdom   12   5   17 
Hungary   69   33   102 
Mexico   24   16   40 
Puerto Rico   39   19   58 
Canada   16   11   27 
Argentina   67   34   101 
Brazil   20   10   30 
Poland   67   32   99 
Romania   40   22   62 
Australia   27   18   45 
South Africa   11   4   15 
Germany   63   36   99 
New Zealand   10   9   19 
Czechia   9   4   13 


  Outcome Measures

1.  Primary:   Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 52 weeks ]

2.  Secondary:   Rate of Total and Nocturnal Hypoglycemia Events   [ Time Frame: Baseline to 52 weeks ]

3.  Secondary:   Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %   [ Time Frame: 52 weeks ]

4.  Secondary:   Fasting Serum Glucose (By Laboratory Measurement)   [ Time Frame: 52 weeks ]

5.  Secondary:   Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)   [ Time Frame: 52 weeks ]

6.  Secondary:   6 Point Self-monitored Blood Glucose (SMBG)   [ Time Frame: 52 weeks ]

7.  Secondary:   Change From Baseline to 52 Weeks in Body Weight   [ Time Frame: Baseline, 52 weeks ]

8.  Secondary:   Hemoglobin A1c   [ Time Frame: 52 weeks ]

9.  Secondary:   Insulin Dose Per Body Weight   [ Time Frame: 52 weeks ]

10.  Secondary:   Number of Insulin Dose Adjustments to Steady-State   [ Time Frame: Baseline to 52 weeks ]

11.  Secondary:   European Quality of Life-5 Dimension (EQ-5D)   [ Time Frame: 52 weeks ]

12.  Secondary:   Insulin Treatment Satisfaction Questionnaire   [ Time Frame: Up to 52 weeks ]

13.  Secondary:   Adult Low Blood Sugar Survey   [ Time Frame: Up to 52 weeks ]

14.  Secondary:   Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: Baseline, 52 weeks ]

15.  Secondary:   Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin   [ Time Frame: Up to 52 weeks ]

16.  Secondary:   Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)   [ Time Frame: Baseline to 78 weeks ]

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

18.  Secondary:   Percentage of Participants With Total and Nocturnal Hypoglycemic Events   [ Time Frame: Baseline to 52 weeks ]

19.  Secondary:   Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia   [ Time Frame: Up to 52 weeks ]

20.  Secondary:   Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)   [ Time Frame: Up to 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: NCT01435616     History of Changes
Other Study ID Numbers: 12141
I2R-MC-BIAJ ( Other Identifier: Eli Lilly and Company )
First Submitted: September 9, 2011
First Posted: September 16, 2011
Results First Submitted: March 16, 2018
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018