A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0148-0000-0287 in Healthy Subjects and in Subjects With Type 1 Diabetes

NCT01730014 Phase 1 COMPLETED

This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	70
Start date	2012-10
Completion	2013-07

Conditions

• Diabetes
• Diabetes Mellitus, Type 1
• Healthy

Interventions

• 148-0287-A-4.2mM-cartridge
• placebo
• 148-0287-A-4.2mM-cartridge
• placebo
• insulin glargine
• sodium chloride 0.9% w/v

Primary outcomes

• Incidence of adverse events (AE) — From trial product administration until completion of the post-treatment follow-up visit at Day 37

Countries

Germany