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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Herston
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Meadowbrook
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [6] 0 0
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
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [5] 0 0
5035 - Keswick
Recruitment postcode(s) [6] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
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Tainan city
Country [219] 0 0
Taiwan
State/province [219] 0 0
Taoyuan
Country [220] 0 0
Turkey
State/province [220] 0 0
Ankara
Country [221] 0 0
Turkey
State/province [221] 0 0
Antalya
Country [222] 0 0
Turkey
State/province [222] 0 0
Bursa
Country [223] 0 0
Turkey
State/province [223] 0 0
Gaziantep
Country [224] 0 0
Turkey
State/province [224] 0 0
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
State/province [232] 0 0
Devon
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Dundee
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Edinburgh
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Glasgow
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Guildford
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Hull
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Livington
Country [239] 0 0
United Kingdom
State/province [239] 0 0
London
Country [240] 0 0
United Kingdom
State/province [240] 0 0
Manchester
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Norwich
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Nuneaton
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Plymouth
Country [244] 0 0
United Kingdom
State/province [244] 0 0
St Helens
Country [245] 0 0
United Kingdom
State/province [245] 0 0
Swansea
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Torquay
Country [247] 0 0
United Kingdom
State/province [247] 0 0
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Marso SP, Daniels GH, Brown-Frandsen K, Kristensen... [More Details]
Journal Petrie JR, Marso SP, Bain SC, Franek E, Jacob S, M... [More Details]
Journal Masmiquel L, Leiter LA, Vidal J, Bain S, Petrie J,... [More Details]
Journal Satman I, R Rea R, Eriksson M, Mosenzon O, Pratley... [More Details]
Journal Rutten GE, Tack CJ, Pieber TR, Comlekci A, Orsted ... [More Details]
Journal Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman ... [More Details]
Journal Steinberg WM, Nauck MA, Zinman B, Daniels GH, Berg... [More Details]
Journal Daniels GH, Hegedus L, Marso SP, Nauck MA, Zinman ... [More Details]
Journal Steinberg WM, Buse JB, Ghorbani MLM, Orsted DD, Na... [More Details]
Journal Mann JFE, Orsted DD, Brown-Frandsen K, Marso SP, P... [More Details]
Journal Hegedus L, Sherman SI, Tuttle RM, von Scholten BJ,... [More Details]
Journal Marso SP, Nauck MA, Monk Fries T, Rasmussen S, Tre... [More Details]
Journal Verma S, Bhatt DL, Bain SC, Buse JB, Mann JFE, Mar... [More Details]
Journal Nauck MA, Jensen TJ, Rosenkilde C, Calanna S, Buse... [More Details]
Journal Zinman B, Marso SP, Christiansen E, Calanna S, Ras... [More Details]
Journal Nauck MA, Tornoe K, Rasmussen S, Treppendahl MB, M... [More Details]
Journal Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L... [More Details]
Journal Verma S, Leiter LA, Mazer CD, Bain SC, Buse J, Mar... [More Details]
Journal Mann JFE, Fonseca V, Mosenzon O, Raz I, Goldman B,... [More Details]
Journal Verma S, Poulter NR, Bhatt DL, Bain SC, Buse JB, L... [More Details]
Journal Nauck MA, Buse JB, Mann JFE, Pocock S, Bosch-Trabe... [More Details]
Journal Zinman B, Nauck MA, Bosch-Traberg H, Frimer-Larsen... [More Details]
Journal Gilbert MP, Bain SC, Franek E, Jodar-Gimeno E, Nau... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01179048