Clinical Trial Results:
An Open-label, Randomized, Multicenter, Phase III Study to Compare the
Immunogenicity, Efficacy, and Safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus® (Insulin Glargine Injection) in Adult Subjects with Type 1 Diabetes Mellitus
Summary
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EudraCT number |
2017-001450-34 |
Trial protocol |
HU CZ ES |
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 |
This version publication date |
14 Jul 2021
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First version publication date |
14 Jul 2021
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Other versions |
v2 |
Summary report(s) |
Response to EudraCT May 2021 |
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.