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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02044848
First received: January 22, 2014
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Secukinumab
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Stimulated C-peptide in response to a standard mixed meal tolerance test [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Amount of C-peptide (a protein that shows how much insulin the body is producing) released in 2 hours during a mixed meal tolerance test. The result of the test performed at screening will be compared against that performed at 52 weeks after the start of treatment.

  • Number of patients with adverse events and serious adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Monitoring of adverse events and serious adverse events on all patients participating in the study.


Secondary Outcome Measures:
  • Total daily dose of insulin [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Total daily dose of insulin will be monitored with the use of a diary of 7 days prior to each study visit.

  • Overall blood glucose control (HbA1c levels) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    HbA1c levels will be monitored at baseline, day 29, weeks 8, 12, 24, 36, and 52, and months 15, 18, 24, 30, and 36 after the start of dosing.

  • Number of hypoglycemic events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The number of hypoglycemic events, especially serious and/or severe ones will be monitored via safety reporting and diary cards ( 7 days before each study visit).

  • Durability of the effect on stimulated C-peptide in response to a mixed meal tolerance test [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    In the event an effect is detected at the end of the 1 year treatment period, evaluation of the durability of effect on the amount of C-peptide (a protein that shows how much insulin the body is producing) released in 2 hours during a mixed meal tolerance test once the treatment period is over. The result of the test performed at screening will be compared against that performed at 52 weeks after the start of treatment, and at the following times during the up to 2 year follow-up period: 15, 18, 24, 30, and 36 months after the start of treatment.


Enrollment: 5
Study Start Date: February 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab
Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Drug: Secukinumab
Placebo Comparator: Placebo
Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   8 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044848

Locations
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02044848     History of Changes
Other Study ID Numbers: CAIN457A2227
Study First Received: January 22, 2014
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
type 1 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014