Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation

T

TikoMed

Status and phase

Enrolling
Phase 2

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Heparin
Drug: IBsolvMIR

Study type

Interventional

Funder types

Industry

Identifiers

NCT03867851
NNCIT-02

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient on a waiting list for islet transplantation
  • Male and female patients age 18 to 60 years of age.
  • Ability to understand and provide written informed consent.
  • Mentally stable and able to comply with the procedures of the study protocol.
  • Clinical history compatible with type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years at the time of enrolment.
  • Documented C-peptide <0.1 nmol/L before first islet transplantation (stimulated in response to a MMTT or other confirmatory method).
  • All subjects must have received medical treatment of their diabetes under the guidance from an experienced endocrinologist. If not previously transplanted the patient must also have;
  • At least one episode of severe hypoglycemia in the past 1 year defined as an event with at least one of the following symptoms; memory loss, confusion, uncontrollable behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness, or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood/plasma glucose level < 54 mg/dl [3.0 mmol/L] or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration OR
  • Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more.

Exclusion criteria

  • 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.
  • Patients with body mass index (BMI) > 30.
  • Insulin requirement > 0.7 Unit/kg/day at screening.
  • Consistently abnormal liver function tests (> 1.5 x ULN on two consecutive measurements > 2 weeks apart) at screening.
  • Proliferative untreated diabetic retinopathy
  • Increased risk for thrombosis (ex. homozygous APC-resistance) or bleeding (INR>1.5)
  • Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin

Patients with increased cardiac risk defined as;

  • unstable coronary artery disease requiring hospitalization or revascularization within 6 months prior to baseline visit
  • chronic heart failure which required hospitalization 30 days prior to baseline visit
  • Patients with active infections, unless treatment is not judged necessary by the investigators
  • 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.
  • Patients with active peptic ulcer disease, symptomatic gallstones or portal hypertension.
  • Patients who are pregnant or breastfeeding, or who intend to become pregnant.
  • Patients of childbearing potential not willing to use adequate double contraception with < 1% failure rate after the screening visit until the last visit.
  • Active alcohol or substance abuse
  • Patients with evidence of high-level sensitization (PRA> 50% with flow cytometry).
  • Patients with psychological conditions that make it unsafe to undergo islet transplantation or which preclude compliance with prescribed therapy
  • HbA1c > IFCC 100 mmol/mol, at screening.
  • Patients with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with IBsolvMIR.
  • Patients participating in or having participated in any other clinical drug studies in the past four weeks.
  • History of bleeding disorders
  • History of severe hypersensitivity
  • Previous known heparin-induced thrombocytopenia (HIT)
  • Patients with severe hepatic or renal impairment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

IBsolvMIR
Experimental group
Description:
Study drug IBsolvMIR administered intravenously at 18 mg/kg on day of transplantation and 3 mg/kg on post-operative days 1, 3, 6.
Treatment:
Drug: IBsolvMIR
Heparin
Active Comparator group
Description:
Heparin treatment according to clinical praxis.
Treatment:
Drug: Heparin

Trial contacts and locations

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Central trial contact

Principal Investigator

Data sourced from clinicaltrials.gov

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