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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02044848
Recruitment Status : Terminated (This study was terminated prematurely by the Sponsor for business reasons only.)
First Posted : January 24, 2014
Results First Posted : October 9, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Secukinumab Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : February 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Secukinumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044848


Locations
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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02044848    
Other Study ID Numbers: CAIN457A2227
First Posted: January 24, 2014    Key Record Dates
Results First Posted: October 9, 2015
Last Update Posted: February 17, 2016
Last Verified: January 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
type 1 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases