Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01175824
First received: August 3, 2010
Last updated: January 24, 2014
Last verified: January 2014
Results First Received: November 12, 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 Low Mixture (LM)
Drug: Insulin Glargine
Drug: Prandial 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
Insulin Lispro Low Mixture Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
Insulin Glargine+Insulin Lispro Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.

Participant Flow:   Overall Study
    Insulin Lispro Low Mixture     Insulin Glargine+Insulin Lispro  
STARTED     236     242  
Received at Least 1 Dose of Study Drug     236     240  
COMPLETED     220     220  
NOT COMPLETED     16     22  
Adverse Event                 2                 1  
Lack of Efficacy                 2                 0  
Lost to Follow-up                 0                 1  
Physician Decision                 0                 4  
Protocol Violation                 2                 5  
Withdrawal by Subject                 3                 7  
Sponsor Decision                 1                 0  
Entry Criteria Not Met                 6                 4  



  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.
Intent-to-treat population: randomized participants who received at least 1 dose of study drug. Participants were analyzed per the assigned treatment arm regardless of the treatment they actually received.

Reporting Groups
  Description
Insulin Lispro Low Mixture Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
Insulin Glargine+Insulin Lispro Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Insulin Lispro Low Mixture     Insulin Glargine+Insulin Lispro     Total  
Number of Participants  
[units: participants]
  236     240     476  
Age  
[units: years]
Mean ± Standard Deviation
  57.4  ± 9.93     57.7  ± 9.12     57.5  ± 9.52  
Gender  
[units: participants]
     
Female     120     142     262  
Male     116     98     214  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     15     17     32  
Asian     80     80     160  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     1     6  
White     133     136     269  
More than one race     3     6     9  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Argentina     40     39     79  
Brazil     20     23     43  
China     15     13     28  
Egypt     5     7     12  
India     40     41     81  
Korea, Republic of     25     26     51  
Mexico     20     20     40  
Romania     38     38     76  
Russian Federation     2     3     5  
Spain     23     23     46  
Turkey     8     7     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)   [ Time Frame: Baseline, 24 weeks ]

2.  Primary:   Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)   [ Time Frame: Baseline, 24 weeks ]

3.  Secondary:   Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint   [ Time Frame: Baseline, 12 weeks ]

4.  Secondary:   Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks   [ Time Frame: 24 weeks ]

5.  Secondary:   Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks   [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

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

7.  Secondary:   Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks   [ Time Frame: 12 weeks, 24 weeks ]

8.  Secondary:   Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks   [ Time Frame: 12 weeks, 24 weeks ]

9.  Secondary:   Change in Weight From Baseline to 12 Weeks and 24 Weeks   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

10.  Secondary:   The Number of Participants With a Hypoglycemic Episodes (Incidence)   [ Time Frame: Baseline through 24 weeks ]

11.  Secondary:   Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks   [ Time Frame: 24 weeks ]

12.  Secondary:   Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks   [ Time Frame: 24 weeks ]

13.  Secondary:   The Rate of Hypoglycemic Episodes   [ Time Frame: Baseline through 24 weeks ]

14.  Secondary:   The Number of Participants With Severe Hypoglycemic Episodes   [ 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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01175824     History of Changes
Other Study ID Numbers: 13493, F3Z-CR-IOQE
Study First Received: August 3, 2010
Results First Received: November 12, 2013
Last Updated: January 24, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Egypt: Ministry of Health, Drug Policy and Planning Center
India: Drugs Controller General of India
Korea: Food and Drug Administration
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Ministry of Health
Turkey: Ministry of Health
China: Food and Drug Administration