PINIT Study: Primary Intranasal Insulin Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 25, 2018

Primary Completion Date

June 7, 2021

Study Completion Date

June 7, 2021

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

intranasal insulin

Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter (formulation containing rH-insulin, benzalkonium chloride, glycerol and water)

OTHER

Placebo

Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter placebo (formulation containing benzalkonium chloride, glycerol and water)

Trial Locations (2)

80804

Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Lehrstuhl für Diabetes und Gestationsdiabetes der Technischen Universität München, München

01307

Klinik und Poliklinik für Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307 Dresden, Germany, Dresden

All Listed Sponsors
collaborator

Technische Universität Dresden

OTHER

collaborator

Ludwig-Maximilians - University of Munich

OTHER

collaborator

Helmholtz Zentrum München

INDUSTRY

collaborator

University Hospital Carl Gustav Carus

OTHER

lead

Technical University of Munich

OTHER

NCT03182322 - PINIT Study: Primary Intranasal Insulin Trial | Biotech Hunter | Biotech Hunter