A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
DiabetesDiabetes Mellitus, Type 2Healthy
Interventions
DRUG

Insulin 320

Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.

DRUG

insulin glargine

As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.

DRUG

placebo

Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.

Trial Locations (1)

41460

Neuss

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY