Back to results

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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Secukinumab

Placebo

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes mellitus

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Secukinumab

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test

Study was terminated and no data were collected for the Outcome Measure.

Secondary Outcome Measures

Full Information

NCT ID

NCT02044848

First Posted

January 22, 2014

Last Updated

January 19, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02044848

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

This study was terminated prematurely by the Sponsor for business reasons only.

Study Start Date

February 2014 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Secukinumab

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test

Description

Study was terminated and no data were collected for the Outcome Measure.

Time Frame

Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

New York City

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs