CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 308 enrolled
Drug / intervention
NNC0114-0006 +2 moredrug
Likely dose
NNC0114-0006 12 mg/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/NCT02443155
NCT02443155Phase 2Completed
CompareCT.gov

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre 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

Novo Nordisk A/S·interventional·Posted May 13, 2015·Updated Apr 9, 2021

In Brief

A Phase 2 clinical trial evaluating NNC0114-0006, liraglutide, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 308 participants across 108 sites in 18 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesAustria, Belgium, Canada, Denmark, Finland, Ireland, Israel, Italy, Norway, Poland, Portugal, Russia, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 13, 2015
Enrollment StartNov 10, 2015
Primary CompletionAug 31, 2018
Study CompletionFeb 27, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.1 years ago

Interventions

NNC0114-0006drug

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

liraglutidedrug

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

placebodrug

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