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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; Iron Deficiency
• Interventions: Drug: NaCl (0,9%); Drug: ferric carboxymaltose

• Registration Number: NCT01513369
• Lead Sponsor: GWT-TUD GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-16
• Study First Posted: 2012-01-20
• Study Start: 2012-08
• Primary Completion: 2018-10
• Study Completion: 2019-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl (0,9%)	NaCl (0,9%)	Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
ferric carboxymaltose	ferric 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

Primary Outcome Measures

Name	Time	Method
reduction in HBA1c-levels	12 weeks	reduction of HbA1c from week 1 (baseline) to week 13

Secondary Outcome Measures

Name	Time	Method
reliability of HbA1c-measurements	12 weeks	measurement of HbA1c in week 0; 5 and 13
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 in quality of life	12 weeks	potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM
Improvement of metabolic status	12 weeks	measurement of fasting glucose, fructosamine
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)

Trial Locations

Locations (6)

Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude; 🇩🇪 Herne, Nordrhein-Westfalen, Germany

Univesitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Sachsen, Germany

Studienzentrum Professor Hanefeld Abakus Büropark; 🇩🇪 Dresden, Germany

Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Germany

Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC; 🇩🇪 Hannover, Germany

Diabetesinstitut Heidelberg; 🇩🇪 Heidelberg, Germany