Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01513369
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01513369
Study Brief:
Protocol Section:
NCT01513369