Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus

Part of paid clinical trials in New York, New York.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02044848
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.

Key Dates

Start date
Feb 28, 2014
Status verified
Jan 2016
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Secukinumab
    Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
  • Placebo Comparator: Placebo
    Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year

Primary Outcome Measure

Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test [ Time Frame: Week 52 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteNew YorkNew York10032-
Novartis Investigative SiteSeattleWashington98122-

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