Clinical trial • Phase I • Endocrinology
insulin glargine for Type 1 diabetes mellitus
Phase I trial of insulin glargine for Type 1 diabetes mellitus.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 1 diabetes mellitus
- Trial Stage
- Phase I
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 15-10-2025
- First CTIS Authorization Date
- 12-12-2025
Trial design
Comparator stated in public title: U.S.-Licensed Lantus® (insulin glargine) versus CVC-001 cartridge; dose and schedule not specified in the record.-controlled Phase I trial across 1 site in Germany.
- Comparator
- Comparator stated in public title: U.S.-Licensed Lantus® (insulin glargine) versus CVC-001 cartridge; dose and schedule not specified in the record.
- Target Sample Size
- 76
Eligibility
Recruits 76 Not a vulnerable population; trial population listed as Healthy volunteers; no assent/consent handling details provided in the record..
- Vulnerable Population
- Not a vulnerable population; trial population listed as Healthy volunteers; no assent/consent handling details provided in the record.
Recruitment
- Planned Sample Size
- 76
- Recruitment Window Months
- 7
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 76
Germany
- Earliest CTIS Part Ii Submission Date
- 19-11-2025
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 168
- Number Of Sites
- 1
- Number Of Participants
- 76
Sites
- Site Name
- PROFIL Institut fuer Stoffwechselforschung GmbH
- Contact Person Name
- Mila Telegravciska
- Contact Person Email
- mila.telegravciska@profil.com
Sponsor
Primary sponsor
- Full Name
- Civica Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- CVC-001 cartridge
- Modality
- Peptide/protein/enzyme
- Authorisation Status
- Investigational
- Investigational Product Name
- U.S.-Licensed Lantus®
- Active Substance
- insulin glargine
- Modality
- Peptide/protein/enzyme
- Authorisation Status
- Licensed (U.S.-Licensed product)
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