Clinical Trial Results:
AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY TO COMPARE THE IMMUNOGENICITY, EFFICACY, AND SAFETY OF GAN & LEE
INSULIN LISPRO INJECTION TO HUMALOG® (INSULIN LISPRO INJECTION) IN ADULT SUBJECTS WITH TYPE 1 DIABETES MELLITUS
Summary
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EudraCT number |
2017-001657-13 |
Trial protocol |
ES PL |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Mar 2022
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First version publication date |
25 Mar 2022
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Other versions |
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Summary report(s) |
Gan & Lee Pharmaceuticals USA Corp. GL-LSPT1-3003 Study Notification |
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.