A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects

NCT01916174 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of two different versions of the insulin degludec/liraglutide combination in healthy adults to see if they are absorbed similarly by the body.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 50 people

Who can join Ages 18–55 · all sexes Healthy volunteers accepted.

Timeline Started 2013-08 · est. completion 2013-11

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT01916174 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.

Treatments tested

insulin degludec/liraglutide Drug

Subject will receive a single injection (s.c.) of IDegLira B5
insulin degludec/liraglutide Drug

Subject will receive a single injection (s.c.) of IDegLira V2

Main thing measured	Area under the serum IDeg concentration time curve after single dose
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2, Healthy
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01916174 ↗