Intravenöse Eisencarboxymaltose-Applikation zur Verbesserung der metabolischen Parameter und der Gefäßfunktion bei Diabetes mellitus Typ 2-Patienten für 12 Wochen (Clever-Studie)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Type 2 Diabetes mellitus
-Ferritin <150 ng/ml or TSAT <25% if Hb <14 g/dl
- Ferritin <100 ng/ml or TSAT <20% if Hb =14 g/dl and=15g/dl]
- HbA1c (%) = 6.5 to < 8.5

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 152

Exclusion Criteria

•Continuous subcutaneous insulin infusion (CSII)
•Thalassaemia
•Hb> 15 g/dl
•Change of HbA1c of more than ±0,3 % within the last 3 months.
•Hypersensitivity to the active substance, to Ferinject® or any of its excipients
•Known serious hypersensitivity to other parenteral iron products
•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 (5 years prior to randomization)
•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 randomization.
•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.
•Female 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
•Failure to use highly-effective contraceptive methods*
•Persons with any kind of dependency on the investigator or employed by the sponsor or investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: reduction in HBA1c-levels between baseline and after 12 weeks of treatment with FCM vs. placebo;Secondary Objective: - improvement of iron status in iron-deficient (ID) type 2 diabetes (T2DM) patients<br>- potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM.<br>- Improvement of metabolic status (fasting glucose, fructosamin)<br>- reliability of HbA1c-measurements in T2DM patients with ID<br>- Improvement in vascular function on the basis of the biomarker ADMA serum level<br>- Change in used insulin dosage during study (via patient diary)<br>;Primary end point(s): •Change in HbA1c-levels between baseline and after 12 weeks of treatment with ferric carboxymaltose i.v. (FCM) vs. placebo.;Timepoint(s) of evaluation of this end point: week 12

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 12 weeks;Secondary end point(s): •Haematological and iron status: Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin<br>•Improvement of metabolic status: fasting glucose, fructosamin<br>•Potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM<br>•Reliability of HbA1c-measurements in T2DM patients with ID.<br>•Change in used insulin dosage during study (via patient diary)<br>•Improvement in vascular function on the basis of the biomarker ADMA serum level [optional]<br>