Iron Deficiency, Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, iron deficiency
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.
Interventions
DRUGferric carboxymaltose
Dose:according to SmPC Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
DRUGNaCl (0,9%)
Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
Sponsors
Vifor Pharma
GWT-TUD GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in HBA1c-levels | 12 weeks | reduction of HbA1c from week 1 (baseline) to week 13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement of haematological and iron status | 12 weeks | Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin |
| Improvement of metabolic status | 12 weeks | measurement of fasting glucose, fructosamine |
| improvement in quality of life | 12 weeks | potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM |
| improvement in vascular function | 12 weeks | Improvement in vascular function on the basis of the biomarker ADMA serum level |
| Change in used insulin dosage during study | 12 weeks | Change in used insulin dosage during study (via patient diary) |
| reliability of HbA1c-measurements | 12 weeks | measurement of HbA1c in week 0; 5 and 13 |
Countries
Germany
Outcome results
None listed