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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01179048




Registration number
NCT01179048
Ethics application status
Date submitted
6/08/2010
Date registered
10/08/2010
Date last updated
17/07/2019

Titles & IDs
Public title
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Scientific title
A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
Secondary ID [1] 0 0
2009-012201-19
Secondary ID [2] 0 0
EX2211-3748
Universal Trial Number (UTN)
Trial acronym
LEADER®
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo

Experimental: Liraglutide -

Placebo Comparator: Placebo -


Treatment: Drugs: liraglutide
Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

Treatment: Drugs: placebo
Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
Timepoint [1] 0 0
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary outcome [2] 0 0
Time From Randomisation to All Cause Death
Timepoint [2] 0 0
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary outcome [3] 0 0
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Timepoint [3] 0 0
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary outcome [4] 0 0
Time From Randomisation to First Occurrence of a Composite Microvascular Outcome
Timepoint [4] 0 0
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Secondary outcome [5] 0 0
Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.
Timepoint [5] 0 0
from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)

Eligibility
Key inclusion criteria
- Type 2 diabetes - Age min. 50 years at screening and concomitant
cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or
chronic heart failure OR age min. 60 years at screening and other specified risk factors of
cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with
one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or
long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor
agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4
(DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin
other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3
months prior to screening. Short-term use of other insulin during this period in connection
with intercurrent illness is allowed, at Investigator's discretion

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/12/2015
Sample size
Target
Accrual to date
Final
9341
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Douglas
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Novo Nordisk Investigational Site - Herston
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Novo Nordisk Investigational Site - Meadowbrook
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Novo Nordisk Investigational Site - Keswick
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Novo Nordisk Investigational Site - Oaklands Park
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Hobart
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [9] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment hospital [10] 0 0
Novo Nordisk Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4814 - Douglas
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4029 - Herston
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4131 - Meadowbrook
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5035 - Keswick
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5046 - Oaklands Park
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7000 - Hobart
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3128 - Box Hill
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3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
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Ankara
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Turkey
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Antalya
Country [222] 0 0
Turkey
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Bursa
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Turkey
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Gaziantep
Country [224] 0 0
Turkey
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Istanbul
Country [225] 0 0
Turkey
State/province [225] 0 0
Izmir
Country [226] 0 0
Turkey
State/province [226] 0 0
Kayseri
Country [227] 0 0
United Arab Emirates
State/province [227] 0 0
Dubai
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Aberdeen
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Birmingham
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Bristol
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Coventry
Country [232] 0 0
United Kingdom
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Devon
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United Kingdom
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Dundee
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Edinburgh
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Glasgow
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Guildford
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Hull
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Livington
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London
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Manchester
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Norwich
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Nuneaton
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Plymouth
Country [244] 0 0
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State/province [244] 0 0
St Helens
Country [245] 0 0
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State/province [245] 0 0
Swansea
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Torquay
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this
trial is to determine the long term effect of liraglutide on cardiovascular events in
subjects with type 2 diabetes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01179048
Trial related presentations / publications
Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.
Hinton W, Feher M, Munro N, Walker M, de Lusignan S. Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Diabetes Obes Metab. 2019 Jul;21(7):1661-1667. doi: 10.1111/dom.13710. Epub 2019 Apr 11.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01179048