A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

NCT02443155 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the medications NNC0114-0006 and liraglutide can help preserve insulin-producing beta-cell function in adults who have recently been diagnosed with type 1 diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 308 people

Who can join Ages 18–45 · all sexes

Timeline Started 2015-11 · est. completion 2019-02

Where 108 sites · Austria, Belgium, Canada, Denmark, Finland, Ireland, Israel, Italy, Norway, Poland, Portugal, Russia, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT02443155 ↗

Description as written by the study sponsor.

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

Treatments tested

NNC0114-0006 Drug

NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
liraglutide Drug

Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
placebo Drug

Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

Main thing measured	Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 1
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02443155 ↗