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Status:

COMPLETED

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

Lead Sponsor:

GWT-TUD GmbH

Collaborating Sponsors:

Vifor Pharma

Conditions:

Type 2 Diabetes Mellitus

Iron Deficiency

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to investigate the correlation between HbA1c and iron status in Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron.

Eligibility Criteria

Inclusion

  • T2DM patients with diagnosis of ID defined as follows:
  • serum ferritin \<150 ng/mL or TSAT \<25% if Hb \< 14 g/dL serum ferritin \<100 ng/mL or TSAT \<20% if Hb ≥ 14 g/dL and ≤ 15g/dL\]
  • HbA1c: ≥ 6.5 to \< 8.5 %
  • Age \> 18 years
  • Written informed consent has been obtained.
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 1 2019

    Estimated Enrollment :

    152 Patients enrolled

    Trial Details

    Trial ID

    NCT01513369

    Start Date

    August 1 2012

    End Date

    April 1 2019

    Last Update

    February 4 2021

    Active Locations (6)

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    Page 1 of 2 (6 locations)

    1

    Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude

    Herne, North Rhine-Westphalia, Germany, 32545

    2

    Univesitätsklinikum Carl Gustav Carus

    Dresden, Saxony, Germany, 01307

    3

    Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum

    Bad Oeynhausen, Germany, 32545

    4

    Studienzentrum Professor Hanefeld Abakus Büropark

    Dresden, Germany, 01307