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Diabetes Mellitus, Type 1Phase 2NCT03867851

Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation

A Phase 2 study testing IBsolvMIR and Heparin in people with Diabetes Mellitus, Type 1, run by TikoMed AB at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
IBsolvMIR and Heparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
5 sitesin 3 countries
Study dates
8 Feb 2021to 13 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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)
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  • 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 locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Sweden3 sites

  • Sahlgrenska sjukhuset

    Gothenburg

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm

  • Akademiska sjukhuset

    Uppsala

Other trials in Sweden

Netherlands1 site

  • Leiden University Medical Center

    Leiden, South Holland, 2300 RC

Other trials in Netherlands

Norway1 site

  • Oslo Universitetssykehus HF

    Oslo

Other trials in Norway

About this study

Official title: Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation

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.

Being tested
IBsolvMIR, Heparin
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBsolvMIRDrug

    Study drug IBsolvMIR

  • HeparinDrug

    Clinical praxis

Study groups in NCT03867851
Study groupRoleWhat they receive
IBsolvMIRExperimentalStudy drug IBsolvMIR administered intravenously at 18 mg/kg on day of transplantation and 3 mg/kg on post-operative days 1, 3, 6.
Receives: Drug: IBsolvMIR
HeparinActive comparatorHeparin treatment according to clinical praxis.
Receives: Drug: Heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bleeding events

    Bleeding events after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator Heparin

    Measured: Up to 44 days.

  2. 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

    Measured: Up to 44 days.

Secondary outcomes (2)

  1. Difference between groups in levels of biomarkers

    Difference between groups in levels of biomarkers after transplantation

    Measured: Within 7 days.

  2. 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) )

    Measured: Within 14 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2019
  2. Study start8 Feb 2021
  3. Primary completion13 May 2024
  4. Study completion13 May 2024

Why it stopped: Slow patient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867851
Sponsor's protocol ID
NNCIT-02
Status last verified
May 2024
First submitted
5 Mar 2019
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBsolvMIR and Heparin in people with Diabetes Mellitus, Type 1, run by TikoMed AB at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow patient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding events (time frame: Up to 44 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03867851.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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