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Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01179048
First received: August 6, 2010
Last updated: January 10, 2017
Last verified: January 2017
Results First Received: December 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: liraglutide
Drug: placebo

  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
410 sites in 32 countries across the 4 regions recruited subjects. Number of sites that recruited subjects is given in parenthesis. Europe (143), North America (135) (US, Canada) , Asia (33) (China, Taiwan, Korea, India) and Rest of the world (99) (Brazil, Mexico, Australia, South Africa, Turkey, Russian Federation, United Arab Emirates).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects received placebo (0.6 mg/day) during the open labeled run-in period of 2-3 weeks and were instructed on how to administer the trial product. During this period the subjects demonstrated that they could adhere to the injection regimen in the trial.

Reporting Groups
  Description
Liraglutide Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Placebo Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.

Participant Flow:   Overall Study
    Liraglutide   Placebo
STARTED   4668   4672 
COMPLETED   4529   4513 
NOT COMPLETED   139   159 
Withdrawn - does not allow contact                4                8 
Lost to Follow-up                8                9 
Alive                127                142 



  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 the randomised subjects.

Reporting Groups
  Description
Liraglutide Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Placebo Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
Total Total of all reporting groups

Baseline Measures
   Liraglutide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 4668   4672   9340 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (7.2)   64.4  (7.2)   64.3  (7.2) 
Age, Customized 
[Units: Participants]
     
Between 18 and 64 years   2512   2499   5011 
Between 65 to 84 years   2139   2148   4287 
85 years and over   17   25   42 
Gender 
[Units: Participants]
Count of Participants
     
Female      1657  35.5%      1680  36.0%      3337  35.7% 
Male      3011  64.5%      2992  64.0%      6003  64.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)   [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]

2.  Secondary:   Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.   [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]

3.  Secondary:   Time From Randomisation to All Cause Death   [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]

4.  Secondary:   Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome   [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications of Results:


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01179048     History of Changes
Other Study ID Numbers: EX2211-3748
2009-012201-19 ( EudraCT Number )
U1111-1113-7090 ( Other Identifier: WHO )
CTR20130003 ( Other Identifier: CFDA )
Study First Received: August 6, 2010
Results First Received: December 16, 2016
Last Updated: January 10, 2017