Clinical Trial Results:
A 26-week randomised, controlled, open label, multicentre, multinational, treat to target trial investigating the impact of dietary intervention on weight change and the relationship between weight change and baseline body mass index (BMI) in subjects with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs) initiating insulin therapy with insulin detemir in combination with metformin
Ensayo aleatorizado, controlado, abierto, multicéntrico, multinacional, de 26 semanas de duración, con ajuste de dosis para investigar los efectos de la intervención dietética sobre el cambio en el peso corporal y la relación entre el cambio en el peso corporal y el índice de masa corporal (IMC) basal en pacientes con diabetes tipo 2 mal controlada en tratamiento con antidiabéticos orales (ADO) que están empezando el tratamiento con insulina detemir en combinación con metformina
Levemir DIET
Summary
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EudraCT number |
2009-014894-42 |
Trial protocol |
ES SK DE SI |
Global completion date |
14 Nov 2011
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Feb 2016
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First version publication date |
05 Sep 2014
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Other versions |
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Summary report(s) |
Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.