This is a Phase II open, randomized, active comparator-controlled multi center study in patients with severe type-1 diabetes. This is a two-armed study where patients are randomized in a 2:1 ratio between IBsolvMIR and heparin. Eighteen patients are planned to be included. The study consists of up to 8 visits; screening, transplantation surgery with bolus administration of study drug or active comparator, IBsolvMIR doses on day 1, 3 and 6 after surgery, follow up visits on day 7 and 14, and follow-up phone call on day 44. The primary endpoint is to study AEs up to 44 days following study drug administration. The secondary endpoints are to evaluate changes in TAT, C-peptide, C3a and HGF at baseline and during the first 24 hours after study drug administration, as well as evaluate a change in levels of C-peptide-glucose-creatinine ratio on day 14 compared to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Study drug IBsolvMIR
Clinical praxis
Leiden University Medical Center
Leiden, South Holland, Netherlands
Oslo Universitetssykehus HF
Oslo, Norway
Sahlgrenska sjukhuset
Gothenburg, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Akademiska sjukhuset
Uppsala, Sweden
Bleeding events
Bleeding events after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator Heparin
Time frame: Up to 44 days.
Other AEs/SAEs after islet transplantation
Other AEs/SAEs after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator Heparin
Time frame: Up to 44 days.
Difference between groups in levels of biomarkers
Difference between groups in levels of biomarkers after transplantation
Time frame: Within 7 days.
Change in C-peptide / (glucose x creatinine) ratio (CPGCR)
Change in CPGCR at day 14 compared to baseline. CPGCR is calculated by: C-peptide (ng/mL) / ( glucose (mg/dL) x creatinine ratio (mg/dL) )
Time frame: Within 14 days.
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