A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

NCT01597713 Phase 1 COMPLETED

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers. The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	83
Start date	2012-05
Completion	2012-10

Conditions

• Diabetes
• Diabetes Mellitus, Type 2
• Healthy

Interventions

• NNC 0148-0000-0362
• insulin glargine
• placebo
• NNC 0148-0000-0362
• NNC 0148-0000-0362
• NNC 0148-0000-0362

Primary outcomes

• Number of adverse events — Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit

Countries

Germany