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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (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
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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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.
No text entered.

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 
Overall Participants Analyzed 
[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 
[1] Patients with previous sulfonylurea use.
Body Mass Index (BMI) [1] 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 30.03  (5.01)   30.10  (5.12)   30.06  (5.06) 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
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) 


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

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 ]

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

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

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

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 ]

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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: 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