Clinical Trial Results:
A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + metformin 500 mg, or of BI 1356 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naïve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control
Summary
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EudraCT number |
2008-001640-40 |
Trial protocol |
NL DE FR SE EE LT |
Global completion date |
26 May 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 |
v2(current) |
This version publication date |
21 Apr 2019
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First version publication date |
05 Apr 2015
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Other versions |
v1 |
Version creation reason |
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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.