A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01175811
First received: August 3, 2010
Last updated: October 29, 2013
Last verified: October 2013
Results First Received: October 29, 2013  
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 Premix
Drug: Insulin Glargine
Drug: Insulin Lispro

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Premixed Insulin

Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Basal-Bolus

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro

Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks


Participant Flow:   Overall Study
    Premixed Insulin     Basal-Bolus  
STARTED     199     203  
Received at Least 1 Dose of Study Drug     197     202  
COMPLETED     183     189  
NOT COMPLETED     16     14  
Adverse Event                 1                 1  
Entry criteria not met                 3                 1  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 3                 2  
Physician Decision                 1                 1  
Protocol Violation                 1                 2  
Withdrawal by Subject                 6                 7  



  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
Premixed Insulin

Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)

Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks

Basal-Bolus

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks

Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks

Total Total of all reporting groups

Baseline Measures
    Premixed Insulin     Basal-Bolus     Total  
Number of Participants  
[units: participants]
  199     203     402  
Age  
[units: years]
Mean ± Standard Deviation
  59.0  ± 9.29     58.1  ± 9.05     58.6  ± 9.17  
Gender  
[units: participants]
     
Female     103     93     196  
Male     96     110     206  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     199     203     402  
Non-Asian     0     0     0  
Region of Enrollment  
[units: participants]
     
Taiwan     18     20     38  
China     157     158     315  
Korea, Republic of     24     25     49  



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

2.  Secondary:   Change in HbA1c From Baseline to 12 Week Endpoint   [ Time Frame: Baseline, 12 weeks ]

3.  Secondary:   The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks   [ Time Frame: 12 weeks, 24 weeks ]

4.  Secondary:   The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.   [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

5.  Secondary:   Daily Dose of Insulin: Total, Basal, and Prandial   [ Time Frame: 24 weeks ]

6.  Secondary:   Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks   [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

7.  Secondary:   Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial   [ Time Frame: 24 weeks ]

8.  Secondary:   Percentage of Participants With Hypoglycemic Episodes (Incidence)   [ Time Frame: baseline through 24 weeks ]

9.  Secondary:   The Rate of Hypoglycemic Episodes   [ Time Frame: baseline through 24 weeks ]

10.  Secondary:   Percentage of Participants Experiencing a Severe Hypoglycemic Episode   [ Time Frame: baseline through 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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01175811     History of Changes
Other Study ID Numbers: 13492, F3Z-CR-IOQD
Study First Received: August 3, 2010
Results First Received: October 29, 2013
Last Updated: October 29, 2013
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan : Food and Drug Administration