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The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes

This study has been terminated.
(Interim analyses demonstrated futility. Thus, recruitment curtailed 10/08.)
Sponsor:
Collaborator:
Sanofi
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00366301
First received: August 17, 2006
Last updated: October 26, 2010
Last verified: October 2010
Results First Received: October 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Insulin glargine injection
Drug: metformin
Drug: Placebo pill

  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
Recruitment occurred at 73 US office-based practices between October 2006 and December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Preenrollment evaluation comprised local laboratory testing of hsCRP,HbA1c, and safety parameters (ALT or AST and creatinine). Eligible participants were enrolled in a 2-week run-in. Ability to self-monitor fingerstick blood glucose and perform insulin injection was determined and evaluation for evidence of marked hyperglycemia was undertaken.

Reporting Groups
  Description
Placebo Pill Placebo pill
Metformin Pill Metformin pill
Insulin Glargine Plus Placebo Pill Insulin glargine plus placebo pill
Insulin Glargine Plus Metformin Pill Insulin Glargine plus metformin pill

Participant Flow:   Overall Study
    Placebo Pill   Metformin Pill   Insulin Glargine Plus Placebo Pill   Insulin Glargine Plus Metformin Pill
STARTED   124   126   126   124 
Either 6W or 14W CRP Obtained   120   124   124   119 
COMPLETED   116   120   122   116 
NOT COMPLETED   8   6   4   8 
Lost to Follow-up                4                4                3                7 
Withdrawal by Subject                4                2                1                1 



  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
Placebo Pill Placebo pill
Metformin Pill Metformin pill
Insulin Glargine Plus Placebo Pill Insulin glargine plus placebo pill
Insulin Glargine Plus Metformin Pill Insulin Glargine plus metformin pill
Total Total of all reporting groups

Baseline Measures
   Placebo Pill   Metformin Pill   Insulin Glargine Plus Placebo Pill   Insulin Glargine Plus Metformin Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 124   126   126   124   500 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Mean (SD)   54.0  (10.9)   53.8  (11.5)   53.8  (11.4)   54.0  (11.7)   53.9  (11.4) 
Gender 
[Units: Participants]
         
Female   64   68   83   66   281 
Male   60   58   43   58   219 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   13   4   19   17   53 
Not Hispanic or Latino   110   119   104   105   438 
Unknown or Not Reported   1   3   3   2   9 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   91   88   95   91   365 
African American   25   34   25   24   108 
Other   8   4   6   9   27 


  Outcome Measures

1.  Primary:   Percentage Reduction in C-reactive Protein (CRP)   [ Time Frame: 14 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 NOT 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.


Results Point of Contact:  
Name/Title: Aruna Pradhan
Organization: Brigham and Women's Hospital
phone: 617-732-8777
e-mail: apradhan@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aruna Das Pradhan, MD, MPH, Brigham & Women's Hospital, Boston, Massachusetts 02115
ClinicalTrials.gov Identifier: NCT00366301     History of Changes
Other Study ID Numbers: 2006-P-000823
Lantus_L_00833
Study First Received: August 17, 2006
Results First Received: October 26, 2010
Last Updated: October 26, 2010
Health Authority: United States: Institutional Review Board