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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00494013
First received: June 27, 2007
Last updated: November 4, 2009
Last verified: November 2009
History of Changes
Results First Received: September 25, 2009  
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: Detemir

  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
789 patients were screened; 347 patients failed screening or discontinued before randomization. Demographics and outcomes are reported on the "Full Analysis Set": all randomized patients who received at least one dose of study drug and had at least one post-baseline measurement for the dependent variable, according to Intent to Treat principles.

Reporting Groups
  Description
Insulin Lispro Protamine Suspension Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Detemir Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Participant Flow:   Overall Study
    Insulin Lispro Protamine Suspension     Detemir  
STARTED     223     219  
Full Analysis Set (Intent to Treat)     219     210  
COMPLETED     193     183  
NOT COMPLETED     30     36  
Adverse Event                 0                 1  
Entry Criteria Not Met                 1                 4  
Lost to Follow-up                 5                 6  
Physician Decision                 3                 5  
Protocol Violation                 8                 5  
Withdrawal by Subject                 13                 14  
Sponsor Decision                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Insulin Lispro Protamine Suspension Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Detemir Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Insulin Lispro Protamine Suspension     Detemir     Total  
Number of Participants  
[units: participants]
 		  219     210     429  
Age  
[units: years]
Mean ± Standard Deviation 		  56.32  ± 9.91     55.73  ± 10.20     56.03  ± 10.04  
Gender  
[units: participants]
 		     
Female     108     97     205  
Male     111     113     224  
Region of Enrollment  
[units: participants]
 		     
Argentina     10     11     21  
Hungary     36     34     70  
India     42     39     81  
Korea, Republic of     10     11     21  
Mexico     28     27     55  
Spain     13     13     26  
Taiwan     20     19     39  
United States     60     56     116  
Race/Ethnicity  
[units: participants]
 		     
African     8     8     16  
Caucasian     88     82     170  
East Asian     35     33     68  
Hispanic     45     47     92  
West Asian     43     40     83  
Sulfonylurea Group [1]
[units: participants]
 		     
Yes     170     158     328  
No     49     51     100  
Unavailable     0     1     1  
Body Mass Index (BMI) [2]
[units: kilogram per square meter  (kg/m^2)]
Mean ± Standard Deviation 		  30.03  ± 5.01     30.10  ± 5.12     30.06  ± 5.06  
Body Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation 		  81.10  ± 17.46     82.72  ± 19.32     81.89  ± 18.39  
Duration of Diabetes  
[units: years]
Mean ± Standard Deviation 		  9.48  ± 6.09     8.94  ± 5.59     9.22  ± 5.85  
Height  
[units: centimeters (cm)]
Mean ± Standard Deviation 		  163.94  ± 10.19     165.14  ± 10.94     164.53  ± 10.57  
[1] Patients with previous sulfonylurea use.
[2] Body mass index is an estimate of body fat based on body weight divided by height squared.



  Outcome Measures
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1.  Primary:   Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 24 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks   [ Time Frame: Baseline, 12 Weeks, 24 Weeks ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 3

4.  Secondary:   Glycemic Variability   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 6

7.  Secondary:   1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 7

8.  Secondary:   30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint   [ Time Frame: Baseline, 24 Weeks ]
  Show Outcome Measure 9

10.  Secondary:   Total Daily Insulin Dose (Units) at Endpoint   [ Time Frame: 24 Weeks ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Total Daily Insulin Dose (Units) at Endpoint
Measure Description Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
Time Frame 24 Weeks  
Safety Issue No  

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.
Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.

Reporting Groups
  Description
Insulin Lispro Protamine Suspension Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Detemir Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.

Measured Values
    Insulin Lispro Protamine Suspension     Detemir  
Number of Participants Analyzed  
[units: participants]
 		  219     210  
Total Daily Insulin Dose (Units) at Endpoint  
[units: Units of insulin]
Mean ± Standard Deviation 		  31.78  ± 19.14     37.30  ± 29.45  


Statistical Analysis 1 for Total Daily Insulin Dose (Units) at Endpoint
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.074
[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:
  ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Secondary:   Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 11

12.  Secondary:   Number of Injections of Basal Insulin Analog at Endpoint   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 12


  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 by Eli Lilly and Company

Publications automatically indexed to this study:


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00494013     History of Changes
Other Study ID Numbers: 10935, F3Z-MC-IOOY
Study First Received: June 27, 2007
Results First Received: September 25, 2009
Last Updated: November 4, 2009
Health Authority: United States: Food and Drug Administration