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Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01773473
First received: January 18, 2013
Last updated: May 4, 2015
Last verified: May 2015
Results First Received: May 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Insulin Lispro Mix25
Drug: Insulin Lispro Mix50

  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
This study consisted of a 26-week treatment period (12-week, weekly-intensive, dose-adjustment period and 14-week maintenance period).

Reporting Groups
  Description
Insulin Lispro Mix25 Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.

Participant Flow:   Overall Study
    Insulin Lispro Mix25   Insulin Lispro Mix50
STARTED   207   196 
Received at Least 1 Dose of Study Drug   207   196 
COMPLETED   191   177 
NOT COMPLETED   16   19 
Adverse Event                3                2 
Protocol Violation                0                4 
Physician Decision                3                5 
Sponsor Decision                2                0 
Lack of Efficacy                0                1 
Non-Compliance with study drug                1                4 
Withdrawal by Subject                5                3 
Lost to Follow-up                2                0 



  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.
All randomized participants.

Reporting Groups
  Description
Insulin Lispro Mix25 Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
Insulin Lispro Mix50 Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
Total Total of all reporting groups

Baseline Measures
   Insulin Lispro Mix25   Insulin Lispro Mix50   Total 
Overall Participants Analyzed 
[Units: Participants]
 207   196   403 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.74  (10.026)   57.34  (9.664)   56.52  (9.871) 
Gender 
[Units: Participants]
     
Female   76   77   153 
Male   131   119   250 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   192   182   374 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   15   14   29 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Turkey   15   14   29 
Japan   88   84   172 
China   80   76   156 
Korea, Republic of   24   22   46 
Duration of Type-2 Diabetes Mellitus (T2DM) 
[Units: Years]
Mean (Standard Deviation)
 9.74  (6.169)   9.15  (6.336)   9.45  (6.250) 


  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26   [ Time Frame: Baseline, Week 26 ]

2.  Secondary:   Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26   [ Time Frame: Baseline through Week 26 ]

3.  Secondary:   Change From Baseline in Fasting Blood Glucose (FBG) at Week 26   [ Time Frame: Baseline, Week 26 ]

4.  Secondary:   Change From Baseline in Body Weight at Week 26   [ Time Frame: Baseline, Week 26 ]

5.  Secondary:   Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)   [ Time Frame: Baseline through Week 26 ]

6.  Secondary:   Insulin Dose at Week 26   [ Time Frame: Week 26 ]

7.  Secondary:   Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26   [ Time Frame: Baseline, Week 26 ]


  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: Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01773473     History of Changes
Other Study ID Numbers: 14675
F3Z-CR-IOQI ( Other Identifier: Eli Lilly and Company )
Study First Received: January 18, 2013
Results First Received: May 4, 2015
Last Updated: May 4, 2015
Health Authority: Japan: Institutional Review Board
South Korea: Institutional Review Board
China: Ethics Committee
Turkey: Ministry of Health
India: Ministry of Health