Diabetes Mellitus Type 1
Conditions
Keywords
severe hypoglycemia, diabetes mellitus, endocrine system diseases, glucose metabolism disorders
Brief summary
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.
Interventions
Allogeneic Pancreatic Endocrine Cell Clusters
Sponsors
Seraxis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Adult 18 to 65 years with a clinical history of T1D * Diagnosis of T1D at \<40 years of age * insulin dependence for ≥5 years at pre-screening * Recurrent severe hypoglycemia * Willingness to use continuous glucose monitoring Key
Exclusion criteria
* Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening * Weight loss medication(s) within 3 months of Screening Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability based on the percentage and relatedness of all treatment emergent adverse events and serious adverse events (TEAEs and SAEs) | day 35 through day 365 |
| The effect on endogenous insulin secretion as assessed by 90-minute MMTT-stimulated C-peptide >0.5 ng/ml (>0.17 nmol/L) | 90 day intervals through day 365 |
Countries
United States
Outcome results
None listed