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

Phase 2

Terminated

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Secukinumab; Drug: Placebo

• Registration Number: NCT02044848
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-09-09
• Results First Submitted QC: 2015-09-09
• Results First Posted: 2015-10-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test	Week 52	Study was terminated and no data were collected for the Outcome Measure.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Seattle, Washington, United States