Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Type 1 Diabetes Mellitus
In brief
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 facts
- Study ID
- NCT02044848
- Run by
- Novartis Pharmaceuticals
- People needed
- 5
- Starts
- 2014-02-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2016-02-17
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — New York, New York, United States
- Novartis Investigative Site — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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