DEFEROXAMINE MESILATE for Type 1 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Patients with diabetes mellitus type 1 with a duration of the disease between 5 and 40 years"}
• {"criterion_text":"- HbA1c 55-100 mmol/mol"}
• {"criterion_text":"- Age 18-55"}
• {"criterion_text":"- Normal ECG result, showing no signs of significant cardiac disorders"}
• {"criterion_text":"- Contraception: Female subjects must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), use a highly effective method of contraception during the study and for 30 days after the last visit. Highly effective methods of contraception are considered to be those listed below: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; or progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine device; or intrauterine hormonereleasing system; or bilateral tubal occlusion; or vasectomised partner; or sexual abstinence"}
• {"criterion_text":"- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Major cardiovascular complications such as coronary heart disease, unstable or stable angina, myocardial infarction, ventricular XML File Identifier: GVRsEn/+aiS1r4rVgVsURkq36HM= Page 11/21 arrhythmias, and atrial fibrillation in the last 3 months"}
• {"criterion_text":"- Definite cardiovascular autonomic dysfunction"}
• {"criterion_text":"- History of anemia, bleeding gastric ulcer, abundant menstruation"}
• {"criterion_text":"- Currently smoking"}
• {"criterion_text":"- History of alcohol or drug abuse"}
• {"criterion_text":"- Infections that necessitated antibiotic therapy during the last month"}
• {"criterion_text":"- Malignancy (with the exception of in situ cancer) that has been declared treated within the last 5 years"}
• {"criterion_text":"- Participant in another ongoing pharmacological study"}
• {"criterion_text":"- Unwillingness to participate following oral and written information"}
• {"criterion_text":"- If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating"}
• {"criterion_text":"- Any concomitant disease or condition that may interfere with the possibility for the subject to comply with or complete the study protocol"}
• {"criterion_text":"- Congestive heart failure (as suggested by anamnesis and by a value of NT-proBNP <155 ng/ml)"}
• {"criterion_text":"- Subjects with any other severe acute or chronic medical or psychiatric condition that make the subject inappropriate for the study in the judgment of the Investigator"}
• {"criterion_text":"- Known hypersensitivity to the active substance"}
• {"criterion_text":"- Treatment with Prochlorperazine"}
• {"criterion_text":"- History of asthma or chronic obstructive pulmonary disease"}
• {"criterion_text":"- Renal insufficiency (cystatin clearance <60 ml/min)"}
• {"criterion_text":"- Liver disease (ALAT/ASAT values >2 times the normal levels or INR > 1,2 or albumin levels < 36 g/ l or total bilirubin < 26 micromol/l or gamma GT <2 mikrokat/l)"}
• {"criterion_text":"- Therapy with β-blockers"}
• {"criterion_text":"- Severe hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)"}
• {"criterion_text":"- Proliferative retinopathy"}
• {"criterion_text":"- Sign for peripheric diabetic neuropathy (decreased/absent sensitivity to 10 g monofilament, vibration, plantar reflex)"}

Primary endpoints

• {"endpoint_text":"- Number of Endothelial Precursor Cells in 10 ml blood after intermittent hypoxia exposure","definition_or_measurement_approach":"Measurement of the number of endothelial precursor cells in 10 ml blood collected after intermittent hypoxia exposure (as stated: 'in 10 ml blood after intermittent hypoxia exposure'). No further measurement details provided in the CTIS record."}

Secondary endpoints

• {"endpoint_text":"- Changes in the levels of angiogenetic chemokines (SDF-1, EPO, VEGF)","definition_or_measurement_approach":"Measurement of changes in circulating levels of listed angiogenetic chemokines (SDF-1, EPO, VEGF); no assay details provided."}
• {"endpoint_text":"- Changes in the levels of angiogenetic and hypoxic induced genes (VEGFA, SDF-1, BPNP3, GLUT3, PDK1)","definition_or_measurement_approach":"Assessment of changes in expression levels of listed genes (VEGFA, SDF-1, BPNP3, GLUT3, PDK1); no methodological details provided."}
• {"endpoint_text":"- Changes in electrophysiological parameters important for the cardiorespiratory response: R-R interval change, the standard deviation of the R-R interval, systolic and diastolic blood pressure, end-tidal carbon dioxide, arterial oxygen saturation, breathing rate, tidal volume, minute ventilation and the ratio between Vt and inspiration time (Vt/Ti), baroreflex sensitivity, arterial function parameters: pulse wave velocity, augmentation index, augmentation index corrected for heart rate (AI75)","definition_or_measurement_approach":"Assessment of listed electrophysiological and cardiorespiratory parameters; no specific measurement methods described in the CTIS record."}

Sweden

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

66

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"Sweden","full_name":"NOVARTIS SVERIGE AB","duties_or_roles":"Marketing authorisation holder / organisation associated with the Desferal product listed in Part I","organisation_type":""}