NCT02044848

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 9, 2015

Completed
Last Updated

February 17, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

January 22, 2014

Results QC Date

September 9, 2015

Last Update Submit

January 19, 2016

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test

    Study was terminated and no data were collected for the Outcome Measure.

    Week 52

Study Arms (2)

Secukinumab

EXPERIMENTAL

Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year

Drug: Secukinumab

Placebo

PLACEBO COMPARATOR

Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year

Drug: Placebo

Interventions

SecukinumabDRUG
Secukinumab
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females aged 18-35 years initially (subjects aged 8-17 may be included at a later stage, starting with age 12-17 years, followed by age 8-11 years).
  • Body weight between 40-120 kg initially (subjects weighing 21-39 kg may be included at a later stage).
  • Recent onset type 1 diabetes mellitus, diagnosed with 100 days of first dose. Peak stimulated C-peptide levels \>/= 0.2 pmol/L following mixed meal tolerance test

You may not qualify if:

  • Any form of diabetes other than auto-immune type 1 (eg, type 2 diabetes, maturity onset diabetes of the young, latent autoimmune diabetes of the adult).
  • Diabetic ketoacidosis within 2 weeks of screening. Pregnancy or lactation. Recent (within 2 weeks of screening), ongoing, chronic or recurrent infectious disease.
  • Active infection with hepatitis B or C, Epstein-Barr virus, cytomegalovirus, or HIV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

New York, New York, 10032, United States

Location

Novartis Investigative Site

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 17, 2016

Results First Posted

October 9, 2015

Record last verified: 2016-01

Locations

US(2)