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Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX) (IOOX)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00377858
First received: September 11, 2006
Last updated: December 4, 2009
Last verified: December 2009
Results First Received: September 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Insulin lispro mid mixture (MM)
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
636 patients were screened; 128 were screen failures; 24 discontinued prior to randomization; 484 patients were randomized. Baseline Characteristics are provided for the Intent to Treat Population, which was defined as patients with baseline and at least one post-baseline value.

Reporting Groups
  Description
Insulin Lispro Mid Mixture Insulin lispro mid mixture (MM) up to three times a day (TID)
Insulin Glargine Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Participant Flow:   Overall Study
    Insulin Lispro Mid Mixture   Insulin Glargine
STARTED   242   242 
Had at Least One Post-Baseline Value   239   240 
COMPLETED   211   215 
NOT COMPLETED   31   27 
Withdrawal by Subject                12                11 
Lost to Follow-up                6                1 
Physician Decision                5                5 
Protocol Violation                3                4 
Adverse Event                2                1 
Entry Criteria Not Met                2                0 
Sponsor Decision                1                2 
Death                0                3 



  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 Mid Mixture Insulin lispro mid mixture (MM) up to three times a day (TID)
Insulin Glargine Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
Total Total of all reporting groups

Baseline Measures
   Insulin Lispro Mid Mixture   Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 239   240   479 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.40  (9.21)   59.45  (9.87)   58.92  (9.55) 
Gender 
[Units: Participants]
     
Female   131   120   251 
Male   108   120   228 
Region of Enrollment 
[Units: Participants]
     
Australia   18   19   37 
Canada   27   24   51 
France   21   19   40 
Greece   19   20   39 
India   26   29   55 
Korea, Republic of   24   25   49 
Mexico   51   47   98 
Russian Federation   24   26   50 
Spain   29   31   60 
Body Mass Index (BMI) Group [1] 
[Units: Participants]
     
BMI <25 kg/m^2   34   48   82 
BMI ≥25 kg/m^2 and <30 kg/m^2   106   103   209 
BMI ≥30 kg/m^2   99   89   188 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
Duration of Diabetes Group 
[Units: Participants]
     
<5 years   28   27   55 
≥5 years and ≤10 years   95   100   195 
>10 years   116   113   229 
Hemoglobin A1c (HbA1c) Group 
[Units: Participants]
     
≤8.5% HbA1c   60   67   127 
>8.5% HbA1c   179   173   352 
Race/Ethnicity 
[Units: Participants]
     
African   2   1   3 
Caucasian   134   136   270 
East Asian   25   27   52 
Hispanic   51   46   97 
West Asian (Indian sub-continent)   27   30   57 
Body Height 
[Units: Centimeters (cm)]
Mean (Standard Deviation)
 163.27  (9.27)   164.68  (9.48)   163.98  (9.39) 
Body Mass Index (BMI) [1] 
[Units: Kilograms per square meter (kg/m^2)]
Mean (Standard Deviation)
 29.51  (4.76)   29.00  (4.55)   29.25  (4.66) 
[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)
 78.85  (15.50)   78.87  (15.10)   78.86  (15.28) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 10.86  (5.54)   11.79  (7.29)   11.33  (6.48) 
Hemoglobin A1c (HbA1c) 
[Units: Percent HbA1c]
Mean (Standard Deviation)
 9.55  (1.18)   9.39  (1.17)   9.47  (1.18) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hemoglobin A1c (HbA1c) at 36 Week Endpoint   [ Time Frame: 36 weeks ]

2.  Secondary:   Hemoglobin A1c (HbA1c) at Interval Visits   [ Time Frame: 12, 24, and 36 weeks ]

3.  Secondary:   Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint   [ Time Frame: 12-24-36 weeks ]

4.  Secondary:   7-point Self-monitored Blood Glucose Profiles   [ Time Frame: Baseline, 12-24-36 weeks ]

5.  Secondary:   Glycemic Variability   [ Time Frame: Baseline, 12-24-36 weeks ]

6.  Secondary:   Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia   [ Time Frame: Baseline to 36 Weeks ]

7.  Secondary:   30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)   [ Time Frame: Baseline to 36 Weeks ]

8.  Secondary:   Number of Patients With at Least One Severe Hypoglycemia Episode   [ Time Frame: Baseline to 36 Weeks ]

9.  Secondary:   Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial   [ Time Frame: 36 Weeks ]

10.  Secondary:   Endpoint Insulin Dose; Total, Basal, and Prandial   [ Time Frame: 36 Weeks ]

11.  Secondary:   Number of Insulin Injections Per Day   [ Time Frame: Weeks 12, 24, 30, 36 ]

12.  Secondary:   Change From Baseline in Absolute Body Weight at 36 Week Endpoint   [ Time Frame: Baseline, 36 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: NCT00377858     History of Changes
Other Study ID Numbers: 10936
F3Z-MC-IOOX
Study First Received: September 11, 2006
Results First Received: September 16, 2009
Last Updated: December 4, 2009