Table 2.

Key inclusion and exclusion criteria

Key inclusion criteria

Men and women older than 18 years Diagnosis of type 2 diabetes and iron deficiency defined as follows:  HbA1c ≥ 48 mmol/mol (6.5%) and < 69 mmol/mol (8.5%)  Serum ferritin < 150 ng/mL or transferrin saturation < 25% if hemoglobin < 14 g/dL  Serum ferritin < 100 ng/mL or transferrin saturation < 20% if hemoglobin ≥ 14 g/dL and ≤ 15 g/dL

Key exclusion criteria

Continuous subcutaneous insulin infusion Thalassemia Hemoglobin > 15 g/dL (≥ 9.31 mmol/L) C-reactive protein > 15 mg/L Change in HbA1c of more than ± 0.3% within the last 3 months Hypersensitivity to ferric carboxymaltose or to any of the excipients of the study medication Known serious hypersensitivity to other parenteral iron products History of acquired iron overload History of erythropoietin-stimulating agent, IV or high-dose oral iron therapy or blood transfusion < 12 weeks prior to randomization Body weight ≤ 40 kg Chronic or active liver disease Vitamin B12 and/or serum folate deficiency Current malignancy under treatment Renal function GFR < 30 mL/min/1.73 m2 Significant major cardiovascular disease ongoing or in the past 3 months Polyneuropathy without ischemia Pregnant or nursing (lactating) women Any person not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication