Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

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
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


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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01175811     History of Changes
Other Study ID Numbers: 13492
F3Z-CR-IOQD ( Other Identifier: Eli Lilly and Company )
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