ferric carboxymaltose in type 2 diabetes mellitus (t2dm) patients with iron deficiency

Conditions: Type 2 Diabetes Mellitus; Iron Deficiency

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:
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

Keywords: diabetes iron deficiency