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A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes (IMAGINE 6)

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ClinicalTrials.gov Identifier: NCT01790438
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : May 3, 2018
Last Update Posted : May 3, 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: Human Insulin NPH
Drug: Oral Antihyperglycemic Medications (OAM)

  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 Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 was given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
Human Insulin NPH Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin isophane suspension (NPH) was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.

Participant Flow:   Overall Study
    LY2605541   Human Insulin NPH
STARTED   428   213 
Received at Least One Dose of Study Drug   427   212 
COMPLETED   393   202 
NOT COMPLETED   35   11 
Adverse Event                3                2 
Death                4                0 
Lost to Follow-up                5                2 
Withdrawal by Subject                13                2 
Physician Decision                3                1 
Sponsor Decision                0                3 
Protocol Required Discontinuation                7                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 enrolled participants.

Reporting Groups
  Description
LY2605541 Administered by SC injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. LY2605541 was given alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
Human Insulin NPH Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin NPH was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
Total Total of all reporting groups

Baseline Measures
   LY2605541   Human Insulin NPH   Total 
Overall Participants Analyzed 
[Units: Participants]
 428   213   641 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.86  (9.76)   59.79  (10.10)   59.17  (9.87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   209   107   316 
Male   219   106   325 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   148   73   221 
Not Hispanic or Latino   195   105   300 
Unknown or Not Reported   85   35   120 
[1] Participants who were not located in the United States were reported in the "Unknown or Not Reported" category for ethnicity.
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   1   0   1 
Asian   53   25   78 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   27   9   36 
White   345   178   523 
More than one race   0   1   1 
Unknown or Not Reported   2   0   2 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   112   60   172 
Hungary   24   11   35 
Czechia   23   12   35 
Mexico   21   11   32 
Puerto Rico   46   19   65 
Canada   25   13   38 
Argentina   31   14   45 
Poland   37   19   56 
Spain   29   16   45 
Germany   30   15   45 
South Korea   50   23   73 
Body Mass Index (BMI) [1] 
[Units: Kilograms/square meters (kg/m^2)]
Mean (Standard Deviation)
 30.80  (5.57)   31.04  (5.03)   30.88  (5.40) 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 10.87  (6.46)   11.40  (7.01)   11.05  (6.65) 


  Outcome Measures

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

2.  Secondary:   30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events   [ Time Frame: Baseline through 26 Weeks ]

3.  Secondary:   Percentage of Participants With HbA1c ≤6.5% and <7.0%   [ Time Frame: 26 Weeks ]

4.  Secondary:   Fasting Serum Glucose (FSG) (by Laboratory)   [ Time Frame: 26 Weeks ]

5.  Secondary:   Fasting Blood Glucose (FBG) (by Self Monitoring)   [ Time Frame: 26 Weeks ]

6.  Secondary:   6-Point Self-Monitored Blood Glucose (SMBG)   [ Time Frame: 26 Weeks ]

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

8.  Secondary:   HbA1c   [ Time Frame: 26 Weeks ]

9.  Secondary:   Insulin Dose Per Kilogram (kg) of Body Weight   [ Time Frame: 26 Weeks ]

10.  Secondary:   Time to Steady-State (Stable Maximum Dose)   [ Time Frame: Baseline through 26 Weeks ]

11.  Secondary:   Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index   [ Time Frame: Baseline, 26 Weeks ]

12.  Secondary:   Insulin Treatment Satisfaction Questionnaire (ITSQ) Score   [ Time Frame: 26 Weeks ]

13.  Secondary:   Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores   [ Time Frame: Baseline, 26 Weeks ]

14.  Secondary:   Change From Baseline to 26 Weeks in Lipid Profile   [ Time Frame: Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks) ]

15.  Secondary:   Percentage of Participants With Insulin Antibodies   [ Time Frame: Baseline to 26 Weeks ]

16.  Secondary:   Intra-Participant Variability in FBG by Standard Deviation   [ Time Frame: 26 Weeks ]

17.  Secondary:   Intra-Participant Variability in FBG by the Coefficient of Variation   [ Time Frame: 26 Weeks ]

18.  Secondary:   Percentage of Participants With Total and Nocturnal Hypoglycemic Events   [ Time Frame: Baseline through 26 Weeks ]

19.  Secondary:   Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia   [ Time Frame: 26 Weeks ]

20.  Secondary:   Percentage of Participants With Injection Site Reactions   [ Time Frame: Baseline through 26 Weeks ]

21.  Secondary:   Rate of Severe Hypoglycemic Events   [ Time Frame: Baseline through 26 Weeks ]

22.  Secondary:   Percentage of Participants With Severe Hypoglycemic Events   [ Time Frame: Baseline through 26 Weeks ]

23.  Secondary:   Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores   [ Time Frame: Baseline, 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: NCT01790438     History of Changes
Other Study ID Numbers: 12143
I2R-MC-BIAK ( Other Identifier: Eli Lilly and Company )
2012-003941-13 ( EudraCT Number )
First Submitted: February 11, 2013
First Posted: February 13, 2013
Results First Submitted: March 16, 2018
Results First Posted: May 3, 2018
Last Update Posted: May 3, 2018