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
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Observ<strong>at</strong>ional study to observe the safety <strong>of</strong> Levemir® tre<strong>at</strong>ment in<br />
children and adolescents with type 1 diabetes<br />
This observ<strong>at</strong>ional study is conducted in Europe.<br />
The trial aims to observe the incidence <strong>of</strong> serious adverse drug reactions in<br />
children and adolescents with type 1 diabetes during Levemir® tre<strong>at</strong>ment.<br />
Scientific Title<br />
Safety <strong>of</strong> Levemir® (insulin detemir) tre<strong>at</strong>ment in children and adolescents<br />
with type 1 diabetes (PREDICTIVE - Youth)<br />
Study IDs and acronym(s)<br />
<strong>Novo</strong> <strong>Nordisk</strong> Trial ID<br />
NN304-1920<br />
<strong>Clinical</strong> <strong>Trials</strong>.gov Registr<strong>at</strong>ion<br />
NCT00704574<br />
Other Identifier(s)<br />
PREDICTIVE<br />
Condition<br />
• Diabetes<br />
• Diabetes Mellitus, Type 2<br />
Study d<strong>at</strong>es<br />
Start d<strong>at</strong>e: 15.Jan.2008<br />
Primary completion d<strong>at</strong>e: 17.Jun.2010<br />
Completion d<strong>at</strong>e: 17.Jun.2010<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 />
• insulin detemir<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: insulin detemir<br />
No extra intervention, only normal clinical practise for tre<strong>at</strong>ment <strong>of</strong> type 1 diabetes<br />
No. <strong>of</strong> study participants<br />
158<br />
Age eligible for study particip<strong>at</strong>ion<br />
6 Years to 18 Years<br />
Genders eligible for study particip<strong>at</strong>ion<br />
Both<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
Inclusion criteria<br />
• Informed consent obtained prior to any trialrel<strong>at</strong>ed<br />
activities<br />
• Any p<strong>at</strong>ient with diabetes type 1 is eligible<br />
for the study, including newly<br />
• The selection <strong>of</strong> the p<strong>at</strong>ients will be <strong>at</strong> the<br />
discretion <strong>of</strong> the individual physician<br />
Exclusion criteria<br />
• Type 2 diabetes<br />
• Currently tre<strong>at</strong>ed with Levemir®<br />
Study type<br />
Observ<strong>at</strong>ional<br />
Study design<br />
Observ<strong>at</strong>ional Model: Case-Only<br />
Time Perspective: Prospective<br />
Study popul<strong>at</strong>ion: Children Age 6 - 18 with<br />
type 1 diabetes<br />
Primary outcome<br />
• Incidence <strong>of</strong> serious adverse drug reactions, • Number <strong>of</strong> all hypoglycaemic events<br />
including major hypoglycaemic events<br />
Time frame: after 6 month tre<strong>at</strong>ment<br />
Secondary outcome(s)<br />
Time frame: after 6 month tre<strong>at</strong>ment<br />
• Number <strong>of</strong> adverse drug reactions<br />
Time frame: after 6 month tre<strong>at</strong>ment<br />
• BMI changes<br />
Time frame: after 6 month tre<strong>at</strong>ment<br />
• HbA1c<br />
Time frame: after 6 month tre<strong>at</strong>ment<br />
• Variability in FPG (Fasting Plasma Glucose)<br />
Time frame: after 6 month tre<strong>at</strong>ment<br />
Particip<strong>at</strong>ing countries<br />
Sweden: Completed<br />
Health authority approval obtained from<br />
Sweden: Medical Products Agency<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: Karin Enarsson, PhD<br />
<strong>Novo</strong> <strong>Nordisk</strong> affili<strong>at</strong>ion: <strong>Novo</strong> <strong>Nordisk</strong> Scandinavia AB<br />
Scientific study public<strong>at</strong>ions<br />
• Carlsson Annelie, Forsander Gun, Ludvigsson Johnny, Larsen Sara, Ortqvist Eva. A<br />
multicenter observ<strong>at</strong>ional safety study in Swedish children and adolescents using insulin<br />
detemir for the tre<strong>at</strong>ment <strong>of</strong> type 1 diabetes. Pedi<strong>at</strong>ric diabetes 2013;<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
Labeling <strong>inform<strong>at</strong>ion</strong><br />
• EU:<br />
http://www.ema.europa.eu/ema/index.jspcurl=pages/medicines/landing/epar_search.jsp&m<br />
url=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125<br />
• US: http://www.accessd<strong>at</strong>a.fda.gov/scripts/cder/drugs<strong>at</strong>fda/<br />
Inform<strong>at</strong>ion provided by <strong>Novo</strong> <strong>Nordisk</strong> A/S<br />
Protocol Inform<strong>at</strong>ion Published: 23.Jun.2008<br />
Protocol Inform<strong>at</strong>ion Last Upd<strong>at</strong>ed: 10.Apr.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
Change language