Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients on Oral Antidiabetic Medication (CLEVER)

Inclusion Criteria:

• T2DM patients on oral anti-diabetic therapy with diagnosis of ID according to KDOQI/EBPG 15 defined as follows:
• serum ferritin < 100 ng/ml (µg/l) or serum ferritin 100 - 300 ng/ml (µg/l) if TSAT is < 20 %
• anemia according to WHO (Hb male < 13 g/dl (8,07 mmol/l), female < 12 g/dL (7.45 mmol/l))
• HbA1c: 7.0 - 10 %
• Age > 18 years
• Written informed consent has been obtained.

Exclusion Criteria:

• Insulin-dependent T2DM
• thalassaemia
• 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 ≤ 35 kg
• Patients presenting with active infection, e.g.: body temperature > 38.5°C or CRP > 10 mg/l.
• Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase > 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).
• 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
• Failure to use highly-effective contraceptive methods *
• Persons with any kind of dependency on the investigator or employed by the sponsor or investigator