Clinical Trial Results:
A Phase II, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (1mg, 5mg, 10mg, 25mg, and 50mg) administered orally once daily over 12 weeks compared double blind to placebo with an additional open-label sitagliptin arm in type 2 diabetic patients with insufficient glycemic control despite metformin therapy
Summary
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EudraCT number |
2008-000641-54 |
Trial protocol |
FI FR ES DE LV AT SK CZ HU EE |
Global completion date |
31 Oct 2009
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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 |
15 Jul 2016
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First version publication date |
15 Jul 2016
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Other versions |
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Summary report(s) |
trial 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.