Clinical Trial Results:
A randomized, double-blind, placebo-controlled, multinational study evaluating the safety and pharmacokinetics of 5 and 10 µg AVE0010 single doses and the efficacy, safety and pharmacokinetics of AVE0010 administered for 5 or 6 weeks, either once or twice daily, following dose escalation from 5 to 30 µg in Japanese and Caucasian type 2 diabetic patients not adequately controlled with sulfonylurea or sulfonylurea and metformin
Summary
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EudraCT number |
2006-003138-13 |
Trial protocol |
DE NL |
Global completion date |
16 Sep 2007
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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 |
04 Jun 2016
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First version publication date |
04 Jun 2016
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Other versions |
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Summary report(s) |
PDY6797 |
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.