Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency

Exclusion Criteria

• •Continuous subcutaneous insulin infusion (CSII)
• •thalassaemia
• •Hb \> 15 g/dL (\> 9,31 mmol/L)
• •Change of HbA1c of more than ±0,3 % within the last 3 months.
• •known sensitivity to ferric carboxymaltose
• •history of acquired iron overload
• •History of erythropoietin stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 12 weeks prior to randomisation
• •History of oral iron therapy at doses ≥ 100 mg/day 1 week prior to randomisation. Note: Ongoing oral use of multivitamins containing iron \< 75 mg/day is permitted.
• •Body weight ≤ 40 kg
• •CRP \> 15 mg/L
• •Chronic liver disease (including known active hepatitis) and/or screening alanine transaminase (ALAT) or aspartate transaminase (ASAT) \> 3 x ULN (upper limit of the normal range).
• •Subjects with known hepatitis B surface antigen positivity and/or Hepatitis C virus ribonucleic acid positivity.
• •Vitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion.
• •Subjects with known seropositivity to human immunodeficiency virus.
• •Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.
• •Currently receiving systemic chemotherapy and/or radiotherapy.
• •Renal dialysis (previous, current or planned within the next 6 months).
• •Renal function GFR \< 30 mL/min/ 1.73m2 (severe)
• •Unstable angina pectoris as judged by the Investigator; severe valvular or left ventricular outflow obstruction disease needing intervention; atrial fibrillation/flutter with a mean ventricular response rate at rest \>100 beats per minute.
• •Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomisation.
• •Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomisation.
• •Patients with a polyneuropathy without ischemia.
• •Subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.
• •Any subject not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
• •Participation in other interventional trials
• •Female subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.
• •Failure to use highly-effective contraceptive methods
• •Persons with any kind of dependency on the investigator or employed by the sponsor or investigator