Pre-POINT-Early Study

PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

Oral Insulin

Total of 12 months treatment; dose escalation scheme: daily treatment with 7.5 mg or placebo for 3 months; increasing to daily treatment with 22.5 mg or placebo for the following 3 months; increasing to daily treatment with 67.5 mg or placebo for the last 6 months of the treatment period.

DRUG

Placebo

Total of 12 months treatment; daily treatment with insulin or placebo capsules containing filling substance (microcrystalline cellulose).

Trial Locations (1)

80804

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

Sponsors
All Listed Sponsors
collaborator

Technische Universität Dresden

OTHER

collaborator

Ludwig-Maximilians - University of Munich

OTHER

collaborator

Helmholtz Zentrum München

INDUSTRY

collaborator

German Center for Diabetes Research

OTHER

lead

Technical University of Munich

OTHER