220
Participants
Start Date
December 11, 2015
Primary Completion Date
September 30, 2024
Study Completion Date
September 30, 2024
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 67.5 mg or placebo for the following 9 months of the treatment period. Follow-up will continue for 24 months after the last administration of treatment.
Placebo
Total of 12 months intervention period; daily administration of insulin or placebo capsules containing filling substance (microcrystalline cellulose). Follow-up will continue for 24 months after the last administration of treatment.
Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Lehrstuhl für Diabetes und Gestationsdiabetes, der Technischen Universität München, München
Technische Universität Dresden
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Helmholtz Zentrum München
INDUSTRY
Technical University of Munich
OTHER