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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GWT-TUD GmbH
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01513369
First received: January 3, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Iron Deficiency
Drug: ferric carboxymaltose
Drug: NaCl (0,9%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency

Resource links provided by NLM:


Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • reduction in HBA1c-levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    reduction of HbA1c from week 1 (baseline) to week 13


Secondary Outcome Measures:
  • improvement of haematological and iron status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin

  • improvement in quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM

  • Improvement of metabolic status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    measurement of fasting glucose, fructosamine

  • reliability of HbA1c-measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    measurement of HbA1c in week 0; 5 and 13

  • improvement in vascular function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in vascular function on the basis of the biomarker ADMA serum level

  • Change in used insulin dosage during study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in used insulin dosage during study (via patient diary)


Estimated Enrollment: 152
Study Start Date: August 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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
Other Name: Ferinject (marketing authorization number: 66227.00.00)
Placebo Comparator: 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
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

T2DM patients with diagnosis of ID defined as follows:

  • Serum ferritin < 100 ng/ml (µg/l) or TSAT is < 20 %
  • HbA1c: ≥ 6.5 to < 8.5 %
  • Age > 18 years
  • Written informed consent has been obtained.

Exclusion Criteria:

  • Continuous subcutaneous insulin infusion (CSII)
  • thalassaemia
  • Hb ≥ 14 g/dl
  • 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
  • Patients presenting with active infection, e.g.: body temperature > 38.5°C or CRP > 10 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513369

Contacts
Contact: Martin Puttrich Martin.Puttrich@GWTonline.de
Contact: Martina Schulze Martina.Schulze@GWTonline.de

Locations
Germany
Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude Active, not recruiting
Herne, Nordrhein-Westfalen, Germany, 32545
Univesitätsklinikum Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Stefan Bornstein, MD       Stefan.Bornstein@uniklinikum-dresden.de   
Principal Investigator: Stefan Bornstein, MD         
Sub-Investigator: Ulrike Schatz, MD         
Sub-Investigator: Babette Engler         
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Active, not recruiting
Bad Oeyenhausen, Germany, 32545
Studienzentrum Professor Hanefeld Abakus Büropark Recruiting
Dresden, Germany, 01307
Contact: Markolf Hanefeld, MD         
Principal Investigator: Markolf Hanefeld, MD         
Sub-Investigator: Wilgard Pohl, MD         
Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC Active, not recruiting
Hannover, Germany, 30625
Diabetesinstitut Heidelberg Recruiting
Heidelberg, Germany, 69115
Contact: Christoph Hasslacher, MD         
Principal Investigator: Christoph Hasslacher, MD         
Sub-Investigator: Benjamin Kulozik, MD         
Sponsors and Collaborators
GWT-TUD GmbH
Vifor Pharma
Investigators
Principal Investigator: Christoph Schindler, MD on behalf of GWT
  More Information

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01513369     History of Changes
Other Study ID Numbers: CLEVER-2011, 2011-005224-18
Study First Received: January 3, 2012
Last Updated: September 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GWT-TUD GmbH:
Diabetes
iron deficiency

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Diabetes Mellitus
Diabetes Mellitus, Type 2
Anemia
Anemia, Hypochromic
Endocrine System Diseases
Glucose Metabolism Disorders
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014