PDF file of registered information - Clinical Trials at Novo Nordisk
PDF file of registered information - Clinical Trials at Novo Nordisk
PDF file of registered information - Clinical Trials at Novo Nordisk
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Observ<strong>at</strong>ional study on efficacy and safety <strong>of</strong> liraglutide in subjects with<br />
type 2 diabetes<br />
This observ<strong>at</strong>ional study is conducted in Europe.<br />
The aim <strong>of</strong> this non-interventional (observ<strong>at</strong>ional) study is to evalu<strong>at</strong>e the<br />
efficacy <strong>of</strong> liraglutide (Victoza®) and to assess the conditions <strong>of</strong> use <strong>of</strong><br />
Victoza® in daily medical practice in France.<br />
Scientific Title<br />
Conditions for prescribing liraglutide in medical practice and assessment <strong>of</strong><br />
maintenance level, tolerability, and efficacy <strong>of</strong> Victoza® (liraglutide) in<br />
subjects with type 2 diabetes<br />
Study IDs and acronym(s)<br />
<strong>Novo</strong> <strong>Nordisk</strong> Trial ID<br />
NN2211-3815<br />
<strong>Clinical</strong> <strong>Trials</strong>.gov Registr<strong>at</strong>ion<br />
NCT01226966<br />
Other Identifier(s)<br />
Other Identifier: U1111-1116-2722<br />
EVIDENCE<br />
Condition<br />
• Diabetes<br />
• Diabetes Mellitus, Type 2<br />
Study d<strong>at</strong>es<br />
Start d<strong>at</strong>e: 11.Oct.2010<br />
Primary completion d<strong>at</strong>e: 11.Oct.2013<br />
Completion d<strong>at</strong>e: 31.Oct.2013<br />
Study st<strong>at</strong>us<br />
Completed<br />
Study phase<br />
Non-interventional/Observ<strong>at</strong>ional<br />
Tre<strong>at</strong>ment<br />
• liraglutide<br />
Group Inform<strong>at</strong>ion with Assigned Tre<strong>at</strong>ment<br />
No. <strong>of</strong> groups: 1<br />
• A<br />
Drug: liraglutide<br />
Prescription is done <strong>at</strong> the discretion <strong>of</strong> the prescribing physician as part <strong>of</strong> normal clinical<br />
routine.<br />
No. <strong>of</strong> study participants<br />
Disclaimer:<br />
This document contains <strong>inform<strong>at</strong>ion</strong> about clinical trials sponsored by <strong>Novo</strong> <strong>Nordisk</strong>. It is not intended to replace the advice <strong>of</strong><br />
a healthcare pr<strong>of</strong>essional and should not be construed as providing advice or making a recommend<strong>at</strong>ion. The <strong>inform<strong>at</strong>ion</strong> on<br />
this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific<br />
product is correct for a particular p<strong>at</strong>ient. If you have questions regarding any <strong>inform<strong>at</strong>ion</strong> contained on this site you should<br />
consult a physician.<br />
http://www.novonordisk-trials.com Page 1
3152<br />
Age eligible for study particip<strong>at</strong>ion<br />
18 Years and above<br />
Genders eligible for study particip<strong>at</strong>ion<br />
Both<br />
Inclusion criteria<br />
• P<strong>at</strong>ients diagnosed with type 2 diabetes<br />
• P<strong>at</strong>ients having recently started (for less<br />
than one week) or starting liraglutide<br />
(Victoza®) tre<strong>at</strong>ment<br />
Exclusion criteria<br />
• Hypersensitivity (allergy) to liraglutide or to<br />
any <strong>of</strong> the excipients<br />
• P<strong>at</strong>ient is particip<strong>at</strong>ing in a clinical trial <strong>at</strong><br />
the inclusion<br />
• Type 1 diabetes<br />
Study type<br />
Observ<strong>at</strong>ional<br />
Study design<br />
Observ<strong>at</strong>ional Model: Cohort<br />
Time Perspective: Prospective<br />
Study popul<strong>at</strong>ion: P<strong>at</strong>ients starting or having<br />
recently started liraglutide tre<strong>at</strong>ment for less<br />
than one week, and s<strong>at</strong>isfying the study<br />
inclusion and exclusion criteria.<br />
Primary outcome<br />
• Percentage <strong>of</strong> p<strong>at</strong>ients still in liraglutide • Change in HbA1c <strong>at</strong> month 3<br />
tre<strong>at</strong>ment and having a HbA1c (glycosyl<strong>at</strong>ed<br />
haemoglobin) value below 7.0%<br />
Time frame: Month 24<br />
Secondary outcome(s)<br />
Time frame: Month 0, Month 3<br />
• Change in HbA1c <strong>at</strong> month 6<br />
Time frame: Month 0, Month 6<br />
• Change in HbA1c <strong>at</strong> month 12<br />
Time frame: Month 0, Month 12<br />
• Change in HbA1c <strong>at</strong> month 18<br />
Time frame: Month 0, Month 18<br />
• Change in HbA1c <strong>at</strong> month 24<br />
Time frame: Month 0, Month 24<br />
• Change in fasting plasma glucose (FPG) <strong>at</strong><br />
month 3<br />
Time frame: Month 0, Month 3<br />
• Change in fasting plasma glucose (FPG) <strong>at</strong><br />
month 6<br />
Time frame: Month 0, Month 6<br />
• Change in fasting plasma glucose (FPG) <strong>at</strong><br />
month 12<br />
Time frame: Month 0, Month 12<br />
• Change in fasting plasma glucose (FPG) <strong>at</strong><br />
month 18<br />
Time frame: Month 0, Month 18<br />
• Change in fasting plasma glucose (FPG) <strong>at</strong><br />
Disclaimer:<br />
This document contains <strong>inform<strong>at</strong>ion</strong> about clinical trials sponsored by <strong>Novo</strong> <strong>Nordisk</strong>. It is not intended to replace the advice <strong>of</strong><br />
a healthcare pr<strong>of</strong>essional and should not be construed as providing advice or making a recommend<strong>at</strong>ion. The <strong>inform<strong>at</strong>ion</strong> on<br />
this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific<br />
product is correct for a particular p<strong>at</strong>ient. If you have questions regarding any <strong>inform<strong>at</strong>ion</strong> contained on this site you should<br />
consult a physician.<br />
http://www.novonordisk-trials.com Page 2
month 24<br />
Time frame: Month 0, Month 24<br />
• Change in Body Weight <strong>at</strong> Month 3<br />
Time frame: Month 0, Month 3<br />
• Change in Body Weight <strong>at</strong> Month 6<br />
Time frame: Month 0, Month 6<br />
• Change in Body Weight <strong>at</strong> Month 12<br />
Time frame: Month 0, Month 12<br />
• Change in Body Weight <strong>at</strong> Month 18<br />
Time frame: Month 0, Month 18<br />
• Change in Body Weight <strong>at</strong> Month 24<br />
Time frame: Month 0, Month 24<br />
Particip<strong>at</strong>ing countries<br />
France: Completed<br />
Health authority approval obtained from<br />
France: Not required for observ<strong>at</strong>ional study<br />
Central contact <strong>inform<strong>at</strong>ion</strong><br />
Study sponsored by: <strong>Novo</strong> <strong>Nordisk</strong> A/S<br />
Contact: clinicaltrials@novonordisk.com<br />
For studies conducted in the US: (+1) 866-867-7178<br />
Study director<br />
Name: Hind Moumane, Medical Advisor<br />
<strong>Novo</strong> <strong>Nordisk</strong> affili<strong>at</strong>ion: <strong>Novo</strong> <strong>Nordisk</strong> A/S<br />
Scientific study public<strong>at</strong>ions<br />
N/A<br />
Labeling <strong>inform<strong>at</strong>ion</strong><br />
N/A<br />
Inform<strong>at</strong>ion provided by <strong>Novo</strong> <strong>Nordisk</strong> A/S<br />
Protocol Inform<strong>at</strong>ion Published: 20.Oct.2010<br />
Protocol Inform<strong>at</strong>ion Last Upd<strong>at</strong>ed: 07.Nov.2013<br />
<strong>PDF</strong> gener<strong>at</strong>ion d<strong>at</strong>e: 21.Jan.2014<br />
Disclaimer:<br />
This document contains <strong>inform<strong>at</strong>ion</strong> about clinical trials sponsored by <strong>Novo</strong> <strong>Nordisk</strong>. It is not intended to replace the advice <strong>of</strong><br />
a healthcare pr<strong>of</strong>essional and should not be construed as providing advice or making a recommend<strong>at</strong>ion. The <strong>inform<strong>at</strong>ion</strong> on<br />
this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific<br />
product is correct for a particular p<strong>at</strong>ient. If you have questions regarding any <strong>inform<strong>at</strong>ion</strong> contained on this site you should<br />
consult a physician.<br />
http://www.novonordisk-trials.com Page 3
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