Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes mellitus
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.
Interventions
DRUGSecukinumab
DRUGPlacebo
Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test | Week 52 | Study was terminated and no data were collected for the Outcome Measure. |
Countries
United States
Participant flow
Recruitment details
Only adult patients were enrolled (no pediatrics as planned) and no one completed the planned treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year | 2 |
| Placebo Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Problems | 2 | 3 |
Baseline characteristics
| Characteristic | Secukinumab | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 24 years STANDARD_DEVIATION 4.24 | 24 years STANDARD_DEVIATION 1.73 | 24 years STANDARD_DEVIATION 2.45 |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 2 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test
Study was terminated and no data were collected for the Outcome Measure.
Time frame: Week 52
Population: Study was terminated and no data were collected for the Outcome Measure