Diabetes Mellitus, Type 1
Conditions
Brief summary
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
Interventions
BIOLOGICALTCD601
Investigational Product
OTHERPlacebo
Comparator
Sponsors
ITB-Med LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Able to understand the study requirements and provide written informed consent before any study assessment is performed * Male or female patients ≥ 18 to 45 years of age * A diagnosis of type 1 diabetes
Exclusion criteria
* Women who are pregnant, lactating, or planning on pregnancy during the study * History of cancer * History of heart disease * Recent infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in beta-cell function as compared to placebo at week 52. | 52 weeks | Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the incidence and severity of adverse | 52 weeks | Number of adverse events compared to placebo at week 52. |
Countries
Belgium, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed