Type 1 Diabetes MedDRA version: 21.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: IBsolvMIR
Product Code: IBsolvMIR
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: IBsolvMIR
CAS Number: 9011-18-1
Other descriptive name: DEXTRAN SULFATE SODIUM
Sponsors
TikoMed AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient on a waiting list for islet transplantation 2. Male and female patients age 18 to 60 years of age. 3. Ability to understand and provide written informed consent. 4. Mentally stable and able to comply with the procedures of the study protocol. 5. Clinical history compatible with type 1 diabetes with onset of disease at 5 years at the time of enrolment. 6. Documented C-peptide =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with prior organ transplants other than a kidney graft and/or islets. A previous pancreas transplant can be accepted if it failed within the first week due to thrombosis and the graft was removed. 2. Patients with body mass index (BMI) > 30. 3. Insulin requirement > 0.7 Unit/kg/day at screening. 4. Consistently abnormal liver function tests (> 1.5 x ULN on two consecutive measurements > 2 weeks apart) at screening. 5. Proliferative untreated diabetic retinopathy 6. Increased risk for thrombosis (ex. homozygous APC-resistance) or bleeding (INR>1.5) 7. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin 8. Patients with increased cardiac risk defined as; o unstable coronary artery disease requiring hospitalization or revascularization within 6 months prior to baseline visit o chronic heart failure which required hospitalization 30 days prior to baseline visit 9. Patients with active infections, unless treatment is not judged necessary by the investigators 10. Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C. 11. Patients with active peptic ulcer disease, symptomatic gallstones or portal hypertension. 12. Patients who are pregnant or breastfeeding, or who intend to become pregnant. 13. Patients of childbearing potential not willing to use adequate double contraception with 50% with flow cytometry). 16. Patients with psychological conditions that make it unsafe to undergo islet transplantation or which preclude compliance with prescribed therapy 17. HbA1c > IFCC 100 mmol/mol, at screening. 18. Patients with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with IBsolvMIR. 19. Patients participating in or having participated in any other clinical drug studies in the past four weeks. 20. History of bleeding disorders 21. History of severe hypersensitivity 22. Previous known heparin-induced thrombocytopenia (HIT) 23. Patients with severe hepatic or renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study safety and tolerability of IBsolvMIR® in comparison to Heparin, in combination with standard immunosuppressive therapy in islet transplantation.;Secondary Objective: • To evaluate the effect of IBsolvMIR on transplant-induced coagulation biomarkers (TAT complexes, D-dimer, platelet consumption,) in comparison to heparin • To evaluate the effect of IBsolvMIR on transplant induced humoral immunity biomarkers (C3a, soluble C5b-9) in comparison to heparin • To evaluate the effect of IBsolvMIR on transplant induced cellular immunity biomarkers (cytokines) in comparison to heparin • To evaluate the effect of IBsolvMIR on engraftment stimulation biomarkers (HGF, VEGF-A, FGF) in comparison to heparin • To evaluate the effect of IBsolvMIR on transplant induced islet destruction biomarkers (C-peptide, soluble TF and PECAM-1) in comparison to heparin • To evaluate the effect of IBsolvMIR on c-peptide/glucose/creatinine ratio at 14 days, compared to baseline and to heparin • To evaluate the pharmacokinetics of IBsolvMIR;Primary end point(s): 1. Bleeding events after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator Heparin 2. Other AEs/SAEs after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to Active comparator Heparin;Timepoint(s) of evaluation of this end point: At 8 visits over 1.5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference between groups in levels of biomarkers after transplant 2. Change in levels of C-peptide/(glucose x creatinine) ratio;Timepoint(s) of evaluation of this end point: For endpoint 1 (all biomarkers except engraftment stimulation biomarkers): at 8 time-points within the first 24 hours from start of transplant, and Before and after dosing day 1, 3, and 6, and at day 7 For endpoint 1 (engraftment stimulation biomarkers): at 10 time-points within the first 24 hours from start of transplant, and Before and after dosing day 1, 3, and 6, and at day 7 For endpoint 2: at 14 days post transplant compared to baseline | — |
Countries
Netherlands, Norway, Sweden
Contacts
Public ContactProject Director IBsolvMIR
TikoMed AB
Outcome results
None listed