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Correction to: Intravenous Ferric Carboxymaltose in Patients with Type 2 Diabetes Mellitus and Iron Deficiency: CLEVER Trial Study Design and Protocol

  • Christoph Schindler
  • Andreas L. Birkenfeld
  • Markolf Hanefeld
  • Ulrike Schatz
  • Carsta Köhler
  • Martin Grüneberg
  • Diethelm Tschöpe
  • Matthias Blüher
  • Christoph Hasslacher
  • Stefan R. Bornstein
Open Access
Correction
  • 51 Downloads

Correction to: Diabetes Ther (2018) 9:37–47  https://doi.org/10.1007/s13300-017-0330-z

In the original publication, the text in Table 2 stated ‘Hypersensitivity to the active substance, to Ferinject, or to any of its excipients’. The authors would like to make changes to the text and have replaced it to ‘Hypersensitivity to ferric carboxymaltose or to any of the excipients of the study medication’. The authors have also made alterations to Fig. 1. Corrected Fig. 1 and Table 2 are given below:
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

Fig. 1

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

Notes

Open Access

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Copyright information

© The Author(s) 2018

Authors and Affiliations

  • Christoph Schindler
    • 1
  • Andreas L. Birkenfeld
    • 2
    • 3
  • Markolf Hanefeld
    • 3
  • Ulrike Schatz
    • 2
  • Carsta Köhler
    • 4
  • Martin Grüneberg
    • 5
  • Diethelm Tschöpe
    • 6
  • Matthias Blüher
    • 7
  • Christoph Hasslacher
    • 8
  • Stefan R. Bornstein
    • 2
  1. 1.Clinical Research Center Hannover and Center for Pharmacology and ToxicologyHannover Medical SchoolHannoverGermany
  2. 2.Medical Clinic and Policlinic III at the University Hospital DresdenDresdenGermany
  3. 3.Centre for Metabolic Vascular Medicine, GWT-TUDDresdenGermany
  4. 4.Medical Consulting, GWT-TUDDresdenGermany
  5. 5.Diabetes Center HerneHerneGermany
  6. 6.Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität BochumBad OeynhausenGermany
  7. 7.Department of Medicine at the University Hospital LeipzigLeipzigGermany
  8. 8.Diabetesinstitut Heidelberg and Department of Clinical StudiesSt. Josefskrankenhaus HeidelbergHeidelbergGermany

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