Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 4/21/2016 |
| Start Date: | February 2014 |
| End Date: | September 2014 |
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)
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.
pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.
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
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