CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
liraglutide +3 moredrug
Likely dose
liraglutide 20 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01507272
NCT01507272Phase 1Completed

A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects

Novo Nordisk A/S·interventional·Posted Jan 10, 2012·Updated Jan 24, 2017

In Brief

A Phase 1 clinical trial evaluating liraglutide and placebo for Diabetes and Healthy. Completed, enrolled 34 participants across 1 site.

Detailed Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Healthy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2012
Enrollment StartMar 1, 1999
Primary CompletionDec 1, 1999
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.5 years ago

Interventions

liraglutidedrug

Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order

liraglutidedrug

Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg

placebodrug

Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered

placebodrug

Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order