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

This study has been terminated.
(This study was terminated prematurely by the Sponsor for business reasons only.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02044848
First received: January 22, 2014
Last updated: January 19, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Secukinumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multiple Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of Secukinumab in Adult and Pediatric Patients With New-onset Type 1 Diabetes Mellitus(T1D)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test [ Time Frame: Week 52 ]
    Study was terminated and no data were collected for the Outcome Measure.


Enrollment: 5
Study Start Date: February 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab
Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Drug: Secukinumab
Placebo Comparator: Placebo
Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Tuberculosis infection. Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044848

Locations
United States, New York
Novartis Investigative Site
New York City, New York, United States, 10032
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02044848     History of Changes
Other Study ID Numbers: CAIN457A2227
Study First Received: January 22, 2014
Results First Received: September 9, 2015
Last Updated: January 19, 2016

Keywords provided by Novartis:
type 1 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 28, 2017