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Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (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;   Endpoint Classification: Safety/Efficacy Study;   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  
Number of Participants  
[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  
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  
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  
[1] 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:   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


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

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
Health Authority: United States: Institutional Review Board