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

Part of paid clinical trials in La Jolla, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT02443155
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Nov 10, 2015
Status verified
Mar 2021
Primary completion
Aug 31, 2018
Completion
Feb 27, 2019

Study Design

Enrollment
308 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0114-0006 + Liraglutide
  • Experimental: NNC0114-0006 + Placebo
  • Active Comparator: Liraglutide + Placebo
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Locations (13)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteLa JollaCalifornia92037-
Novo Nordisk Investigational SiteNorthridgeCalifornia91325-
Novo Nordisk Investigational SiteAuroraColorado80045-
Novo Nordisk Investigational SiteMiamiFlorida33136-
Novo Nordisk Investigational SiteOrlandoFlorida32804-
Novo Nordisk Investigational SiteAtlantaGeorgia30318-
Novo Nordisk Investigational SiteLexingtonKentucky40503-
Novo Nordisk Investigational SiteLas VegasNevada89128-
Novo Nordisk Investigational SiteTeaneckNew Jersey07666-
Novo Nordisk Investigational SiteChapel HillNorth Carolina27517-
Novo Nordisk Investigational SiteNashvilleTennessee37203-
Novo Nordisk Investigational SiteHoustonTexas77079-
Novo Nordisk Investigational SiteMesquiteTexas75149-

Find similar trials in La Jolla, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Novo Nordisk Investigational Site· La Jolla, CANovo Nordisk Investigational Site· Northridge, CANovo Nordisk Investigational Site· Aurora, CONovo Nordisk Investigational Site· Miami, FLNovo Nordisk Investigational Site· Orlando, FLNovo Nordisk Investigational Site· Atlanta, GA

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