Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Secukinumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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.
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|Ages Eligible for Study:||18 Years to 35 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
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
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
|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|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Responsible Party:||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||January 24, 2014 Key Record Dates|
|Results First Posted:||October 9, 2015|
|Last Update Posted:||February 17, 2016|
|Last Verified:||January 2016|
type 1 diabetes mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases