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PK/PD Similarity of HEC-Glargine vs US-Lantus in Healthy Males
NCT05248841Phase 1Completed
- Sponsor
- Lannett
- Start
- Mar 2022
- Primary completion
- Aug 2022
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of insulin glargine in type 1 diabetes mellitus (T1D) and type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Lannett. Primary endpoints: Area under the concentration-time curve from 0 hours to 24 hours, Maximum observed plasma exogenous insulin glargine concentration at Day 2 and 2 more. Started Mar 2022; status: completed.
02
Drugs
insulin glargine
03
Conditions
type 1 diabetes mellitus (T1D)type 2 diabetes mellitus (T2DM)
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