Clinical Trial Results:
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2
Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and
Pharmacodynamics of Dapagliflozin in Subjects with Type 2 Diabetes Mellitus and
Moderate Renal Impairment Who Have Inadequate Glycemic Control.
“Ensayo de fase 2, multicéntrico, en doble ciego, controlado con placebo, de grupos paralelos y aleatorizado, para evaluar la eficacia hipoglucemiante, la seguridad renal, la farmacocinética y la farmacodinámica de dapagliflozin en sujetos con diabetes mellitus tipo 2 e insuficiencia renal moderada con un inadecuado control glucémico"
Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 10-Apr-2008). And Pharmacogenetics Blood Sample Amendment 01 - Site specific (Version 2.0, Date 10-Mar-2008).
Summary
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EudraCT number |
2008-001921-33 |
Trial protocol |
ES DK FR IT |
Global completion date |
01 Jun 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 |
24 Nov 2016
|
First version publication date |
24 Nov 2016
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Other versions |
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Summary report(s) |
CSR |
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.