Clinical Trial Results:
A randomised, parallel-group, open-labelled, multinational trial comparing the efficacy and safety of insulin detemir (Levemir®) versus human insulin (NPH insulin), used in combination with insulin aspart as bolus insulin, in the treatment of pregnant women with type 1 diabetes
Trial Phase: 3b
Summary
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EudraCT number |
2006-004861-33 |
Trial protocol |
IE AT ES FR FI DK GB |
Global completion date |
05 Aug 2010
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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.