A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

NCT02100475 · Completed

Last updated 2026-05-28

This trial compares adding insulin aspart to existing treatment versus increasing the dose of insulin degludec/liraglutide in adults with type 2 diabetes who are already taking insulin degludec/liraglutide and metformin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 31 people

Who can join Ages 18+ · all sexes

Timeline Started 2014-04 · est. completion 2015-04

Where 60 sites · Argentina, Australia, Greece, Hungary, Mexico, Russia, Slovakia, South Africa, Spain, United States

What this study is testing ClinicalTrials.gov NCT02100475 ↗

Description as written by the study sponsor.

This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification. This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

Treatments tested

insulin degludec/liraglutide Drug

Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin. Dose individually adjusted.
insulin aspart Drug

Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.

Main thing measured	Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02100475 ↗