Correction to: Intravenous Ferric Carboxymaltose in Patients with Type 2 Diabetes Mellitus and Iron Deficiency: CLEVER Trial Study Design and Protocol
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Correction to: Diabetes Ther (2018) 9:37–47 https://doi.org/10.1007/s13300-017-0330-z
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 |
CLEVER study design. #Defined as HbA1c ≥ 48 mmol/mol (6.5%) and < 69 mmol/mol (8.5%). ##Defined as serum ferritin < 150 ng/mL or transferrin saturation < 25% if hemoglobin < 14 g/dL or serum ferritin < 100 ng/mL or transferrin saturation < 20% if hemoglobin ≥ 14 g/dL and ≤ 15 g/dL. *Control parameter: ferritin and transferrin saturation. **If still iron deficient at V2a [serum ferritin < 150 ng/mL or transferrin saturation < 25%], an additional dose of 500 mg ferric carboxymaltose is given at V2b, otherwise it is not
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