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This study was terminated prematurely by the Sponsor for business reasons only.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year |
|
| Placebo | Placebo Comparator | Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test | Study was terminated and no data were collected for the Outcome Measure. | Week 52 |
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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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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | New York | New York | 10032 | United States | ||
| Novartis Investigative Site |
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Only adult patients were enrolled (no pediatrics as planned) and no one completed the planned treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab | Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year |
| FG001 | Placebo | Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab | Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year |
| BG001 | Placebo | Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study was terminated and no data were collected for the Outcome Measure | Posted | Week 52 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab | Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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Placebo |
|
| Seattle |
| Washington |
| 98122 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo | Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year | 0 | 3 | 2 | 3 |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Blood ketone body | Investigations | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |