Desferal administration to improve the impaired reaction to hypoxia in diabetes (DESIRED) - A randomised, double-blind, placebo-controlled, cross-over study

Prior treatment

• Any concomitant disease or condition that may interfere with the possibility for the subject to comply with or complete the study protocol
• Treatment with Prochlorperazine
• Therapy with β-blockers

Other illness

• 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
• History of anemia, bleeding gastric ulcer, abundant menstruation
• History of alcohol or drug abuse
• Infections that necessitated antibiotic therapy during the last month
• Malignancy (with the exception of in situ cancer) that has been declared treated within the last 5 years
• Congestive heart failure (as suggested by anamnesis and by a value of NT-proBNP <155 ng/ml)
• 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
• Known hypersensitivity to the active substance
• History of asthma or chronic obstructive pulmonary disease
• Severe hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)

Lab values

• If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
• Renal insufficiency (cystatin clearance <60 ml/min)
• 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)

Other

• Definite cardiovascular autonomic dysfunction
• Currently smoking
• Participant in another ongoing pharmacological study
• Unwillingness to participate following oral and written information
• Proliferative retinopathy
• Sign for peripheric diabetic neuropathy (decreased/absent sensitivity to 10 g monofilament, vibration, plantar reflex)

• Patients with diabetes mellitus type 1 with a duration of the disease between 5 and 40 years
• HbA1c 55-100 mmol/mol
• Age 18-55
• Normal ECG result, showing no signs of significant cardiac disorders
• 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
• Signed informed consent