Liraglutide Effect and Action in Diabetes

Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular
outcome Results
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.
Scientific Title
A Long-term, Multi-centre, International, Randomised Double-blind,
Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular
Events
Trial IDs and acronym(s)
Novo Nordisk Trial ID
EX2211-3748
Clinical Trials.gov Registration
NCT01179048
Other Identifier(s)
EudraCT Number: 2009-012201-19
Other Identifier: U1111-1113-7090
Other Identifier: CTR20130003
LEADER®
Condition
Diabetes
Diabetes Mellitus, Type 2
Trial dates
Start date: 31.Aug.2010
Primary completion date: 17.Dec.2015
Completion date: 17.Dec.2015
Trial phase
Phase 3
Treatment
• liraglutide
• placebo
Arm Information with Assigned Treatment
No. of arms: 2
• Liraglutide (Experimental):
Arm description:
Drug: liraglutide
Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily.
Administered in addition to the subject's standard treatment
• Placebo (Placebo Comparator):
Arm description:
Disclaimer:
This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of
a healthcare professional and should not be construed as providing advice or making a recommendation. The information on
this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific
product is correct for a particular patient. If you have questions regarding any information contained on this site you should
consult a physician.
http://www.novonordisk-trials.com
Page 1
Drug: placebo
Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily.
Administered in addition to the subject's standard treatment
Trial status
Completed
No. of trial participants
9340
Age eligible for trial participation
50 Years and above
Genders eligible for trial participation
Both
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 longacting insulin analogue or premixed insulin,
alone or in combination with OAD(s)
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
Trial type
Interventional
Trial design
Purpose: Treatment
Allocation: Randomized
Masking: Double blind
Control: Placebo Control
Assignment: Parallel Assignment
Endpoint: Safety/Efficacy Study
Primary outcome
• 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 up to 60
months
Secondary outcome(s)
• Time from rand. to first occurrence of an
expanded composite cardiovascular outcome
defined as either cardiovascular death, nonfatal myocardial infarction, non-fatal stroke,
cor. revascularisation, hospitalisation for
unstable angina or heart failure
Time frame: from randomisation up to 60
months
• Time from randomisation to all cause death
Time frame: from randomisation up to 60
Disclaimer:
This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of
a healthcare professional and should not be construed as providing advice or making a recommendation. The information on
this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific
product is correct for a particular patient. If you have questions regarding any information contained on this site you should
consult a physician.
http://www.novonordisk-trials.com
Page 2
months
• Time from randomisation to each individual
component of the expanded composite
cardiovascular outcome
Time frame: from randomisation up to 60
months
Participating countries
Australia: Completed
Austria: Completed
Belgium: Completed
Brazil: Completed/Suspended
Canada: Completed/Suspended
China: Completed/Suspended
Czech Republic: Completed
Denmark: Completed
Finland: Completed
France: Completed
Germany: Completed/Suspended
Greece: Completed/Suspended
India: Completed/Suspended
Ireland: Completed
Israel: Completed
Italy: Completed/Suspended
Korea, Republic of: Completed
Mexico: Completed/Suspended
Netherlands: Completed
Norway: Completed
Poland: Completed
Romania: Completed
Russian Federation: Completed/Suspended
Serbia: Completed
South Africa: Completed
Spain: Completed/Suspended
Sweden: Completed
Taiwan: Completed
Turkey: Completed
United Arab Emirates: Completed
United Kingdom: Completed
United States: Completed/Suspended
Central contact information
Trial sponsored by: Novo Nordisk A/S
Contact: [email protected]
For trials conducted in the US: (+1) 866-867-7178
Disclaimer:
This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of
a healthcare professional and should not be construed as providing advice or making a recommendation. The information on
this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific
product is correct for a particular patient. If you have questions regarding any information contained on this site you should
consult a physician.
http://www.novonordisk-trials.com
Page 3
Scientific trial publications
N/A
Labeling information
• EU:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&m
url=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125
• US: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Information provided by Novo Nordisk A/S
PDF generation date: 24.Apr.2017
Disclaimer:
This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of
a healthcare professional and should not be construed as providing advice or making a recommendation. The information on
this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific
product is correct for a particular patient. If you have questions regarding any information contained on this site you should
consult a physician.
http://www.novonordisk-trials.com
Page 4

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