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

Type 1 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02044848
• Other study ID #: CAIN457A2227
• Status: Terminated
• Phase: Phase 2
• First received: January 22, 2014
• Last updated: January 19, 2016
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Secukinumab

• Placebo
Placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	New York City	New York
United States	Novartis Investigative Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No