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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00560417
First received: November 15, 2007
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
Results First Received: November 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Insulin Lispro Protamine Suspension
Drug: Insulin Glargine

  Participant Flow
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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
Intention to Treat (ITT) Population consisted of all randomized participants who received at least one dose of study drug and had at least one post-baseline measurement.

Reporting Groups
  Description
ILPS Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Participant Flow:   Overall Study
    ILPS     Glargine  
STARTED     171     168  
Intention to Treat (ITT) Population     170     167  
COMPLETED     154     151  
NOT COMPLETED     17     17  
Adverse Event                 3                 2  
Entry Criteria Not Met                 1                 0  
Lost to Follow-up                 0                 1  
Physician Decision                 2                 6  
Protocol Violation                 6                 5  
Sponsor Decision                 2                 0  
Withdrawal by Subject                 3                 3  



  Baseline Characteristics
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Reporting Groups
  Description
ILPS Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
Total Total of all reporting groups

Baseline Measures
    ILPS     Glargine     Total  
Number of Participants  
[units: participants]
 		  171     168     339  
Age  
[units: years]
Mean ± Standard Deviation 		  56.51  ± 9.73     56.24  ± 9.33     56.38  ± 9.52  
Gender  
[units: participants]
 		     
Female     95     75     170  
Male     76     93     169  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black or African American     13     14     27  
East Asian     5     6     11  
Hispanic     21     17     38  
Native American     0     1     1  
West Asian (Indian sub-continent)     2     0     2  
White     130     130     260  
Region of Enrollment  
[units: participants]
 		     
United States     165     165     330  
Puerto Rico     6     3     9  
Body Mass Index [1]
[units: kilograms/square meters (kg/m^2)]
Mean ± Standard Deviation 		  34.92  ± 5.21     34.78  ± 5.17     34.85  ± 5.18  
Body Weight  
[units: Kilograms]
Mean ± Standard Deviation 		  101.57  ± 18.67     102.33  ± 19.73     101.95  ± 19.18  
Hemoglobin A1C  
[units: percent of glycosylated hemoglobin]
Mean ± Standard Deviation 		  8.21  ± 0.79     8.22  ± 0.80     8.22  ± 0.79  
Sulfonylurea Group [2]
[units: participants]
 		     
Yes     108     110     218  
No     63     58     121  
Duration of Diabetes  
[units: years]
Mean ± Standard Deviation 		  9.51  ± 5.98     10.31  ± 6.63     9.91  ± 6.31  
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
[2] Participants taking a sulfonylurea at baseline.



  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])   [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)   [ Time Frame: 24 weeks, Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)   [ Time Frame: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%   [ Time Frame: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 4

5.  Secondary:   7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)   [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Glycemic Variability at Baseline and Endpoint (LOCF)   [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)   [ Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)   [ Time Frame: Baseline to Endpoint (LOCF) up to 24 weeks ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Measure Description Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.
Time Frame Baseline to Endpoint (LOCF) up to 24 weeks  
Safety Issue Yes  

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 with at least one post-baseline measurement. Intention to Treat (ITT) population.

Reporting Groups
  Description
ILPS Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
Glargine Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Measured Values
    ILPS     Glargine  
Number of Participants Analyzed  
[units: participants]
 		  170     167  
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)  
[units: episodes/participant/365 days]
Mean ± Standard Deviation 		   
All reported episodes rate - Endpoint     14.51  ± 27.75     15.29  ± 29.73  
All reported episodes rate - Overall     16.27  ± 23.19     18.05  ± 24.59  
Non-Nocturnal reported episodes rate - Endpoint     10.40  ± 23.46     13.20  ± 28.01  
Non-Nocturnal reported episodes rate - Overall     11.36  ± 19.16     14.83  ± 21.00  
Nocturnal reported episodes rate - Endpoint     4.01  ± 9.73     1.73  ± 5.53  
Nocturnal reported episodes rate - Overall     4.88  ± 8.43     3.01  ± 7.21  


Statistical Analysis 1 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Groups [1] All groups
Method [2] Negative Binomial regression model
P Value [3] 0.628
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value is for All reported episodes rate - Endpoint.

Statistical Analysis 2 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Groups [1] All groups
Method [2] Negative Binomial regression model
P Value [3] 0.570
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value is for All reported episodes rate - Overall.

Statistical Analysis 3 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Groups [1] All groups
Method [2] Negative Binomial regression model
P Value [3] 0.116
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value is for Non-Nocturnal reported episodes rate - Endpoint.

Statistical Analysis 4 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Groups [1] All groups
Method [2] Negative Binomial regression model
P Value [3] 0.044
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value is for Non-Nocturnal reported episodes rate - Overall.

Statistical Analysis 5 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Groups [1] All groups
Method [2] Negative Binomial regression model
P Value [3] 0.006
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value is for Nocturnal reported episodes rate - Endpoint.

Statistical Analysis 6 for Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Groups [1] All groups
Method [2] Negative Binomial regression model
P Value [3] 0.004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-value is for Nocturnal reported episodes rate - Overall.



9.  Secondary:   Actual Body Weight at Baseline and Endpoint (LOCF)   [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Body Weight at Endpoint (LOCF)   [ Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Total Daily Insulin Dose at Endpoint (LOCF)   [ Time Frame: Endpoint (LOCF) up to 24 weeks ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00560417     History of Changes
Other Study ID Numbers: 11647, F3Z-US-IOPB
Study First Received: November 15, 2007
Results First Received: November 12, 2010
Last Updated: January 12, 2011
Health Authority: United States: Food and Drug Administration