Clinical trial • Phase III • Endocrinology
Insulin GZR4 for Type 2 diabetes mellitus
Phase III trial of Insulin GZR4 for Type 2 diabetes mellitus. Insulin Degludec; Insulin Icodec (doses and schedules not specified in source)-controlled.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes mellitus
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 23-06-2025
- First CTIS Authorization Date
- 06-08-2025
Trial design
Insulin Degludec; Insulin Icodec (doses and schedules not specified in source)-controlled Phase III trial across 1 site in Germany.
- Comparator
- Insulin Degludec; Insulin Icodec (doses and schedules not specified in source)
Eligibility
Recruits 14 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in source.
Recruitment
- Recruitment Window Months
- 9
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 14
Germany
- Earliest CTIS Part Ii Submission Date
- 31-07-2025
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 126
- Number Of Sites
- 1
- Number Of Participants
- 14
Sites
- Site Name
- PROFIL Institut fuer Stoffwechselforschung GmbH
- Contact Person Name
- Mila Telegravciska
- Contact Person Email
- mila.telegravciska@profil.com
- Number Of Participants
- 14
Sponsor
Primary sponsor
- Full Name
- Gan & Lee Pharmaceuticals USA Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Insulin GZR4
- Active Substance
- Insulin GZR4
- Modality
- Peptide/protein/enzyme
- Investigational Product Name
- Insulin Degludec
- Active Substance
- Insulin Degludec
- Modality
- Peptide/protein/enzyme
- Investigational Product Name
- Insulin Icodec
- Active Substance
- Insulin Icodec
- Modality
- Peptide/protein/enzyme
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