A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes

PHASE1CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
DiabetesDiabetes Mellitus, Type 1Healthy
Interventions
DRUG

148-0287-A-4.2mM-cartridge

In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.

DRUG

placebo

In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.

DRUG

148-0287-A-4.2mM-cartridge

In a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.

DRUG

placebo

In a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.

DRUG

insulin glargine

In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.

DRUG

sodium chloride 0.9% w/v

In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B.

Trial Locations (1)

41460

Neuss

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY