Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
Part of paid clinical trials in New York, New York.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT02044848
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 35 Years
- Healthy Volunteers
- Not accepted
Interventions
- Secukinumab — DRUG
- Placebo — DRUGPlacebo
Study Details
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.
Key Dates
- Start date
- Feb 28, 2014
- Status verified
- Jan 2016
- Primary completion
- Sep 30, 2014
- Completion
- Sep 30, 2014
Study Design
- Enrollment
- 5 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SecukinumabSecukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
- Placebo Comparator: PlaceboPlacebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Primary Outcome Measure
Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test [ Time Frame: Week 52 ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Novartis Investigative Site | New York | New York | 10032 | - |
| Novartis Investigative Site | Seattle | Washington | 98122 | - |
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