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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02044848

CAIN457A2227

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

Secukinumab

Experimental group

Description:

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

Treatment:

Drug: Secukinumab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo