Study S001615

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

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02443155
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 308
Start: 2015-11-10
Primary completion: 2018-08-31
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 1
Interventions: DRUG:NNC0114-0006; DRUG:liraglutide; DRUG:placebo
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2014-001215-39; OTHER:U1111-1154-7172; REGISTRY:REec-2015-1768; NIH:2014

Registered primary outcomes

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline [0 - 4 hours post-dose on week 0 and week 54]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0023832	Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial. von Herrath M, The lancet. Diabetes & endocrinology	2021	Randomized trial	PMID 33662334 DOI	cites ClinicalTrials.gov:NCT02443155; registry reference RESULT:33662334
R0050083	278-OR: Efficacy and Safety of Anti-interleukin (IL)-21 in Combination with Liraglutide in Adults Recently Diagnosed with Type 1 Diabetes Matthias G. von Herrath, Diabetes	2020	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02443155