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

This study is currently recruiting participants.
Verified January 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: January 16, 2014
Last verified: January 2014

January 3, 2012
January 16, 2014
August 2012
July 2015   (final data collection date for primary outcome measure)
reduction in HBA1c-levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
reduction of HbA1c from week 1 (baseline) to week 13
reduction in HBA1c-levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
reduction of HbA1c from baseline to week 12
Complete list of historical versions of study NCT01513369 on ClinicalTrials.gov Archive Site
  • 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)
  • improvement of iron status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    improvement of iron status in iron-deficient anemic (IDA) non-insulin-dependent (NID) type 2 diabetes (T2DM) patients
  • improvement in quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    potential clinical improvement and improvement in quality of life (QoL, EQ5D) of patients with IDA T2DM (non-insulin-dependent)
  • Improvement of metabolic status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    measurement of fasting glucose, fructosamin
  • reliability of HbA1c-measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    measurement of HbA1c in week 0; 4 and 12
  • improvement in vascular function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    measurement of pulse wave analysis and pulse wave velocitiy
Not Provided
Not Provided
 
Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Iron Deficiency
  • 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)
  • 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
  • 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
    Intervention: Drug: ferric carboxymaltose
  • 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
    Intervention: Drug: NaCl (0,9%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
November 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Martin Puttrich Martin.Puttrich@GWTonline.de
Contact: Martina Schulze Martina.Schulze@GWTonline.de
Germany
 
NCT01513369
CLEVER-2011, 2011-005224-18
No
GWT-TUD GmbH
GWT-TUD GmbH
Vifor Pharma
Principal Investigator: Christoph Schindler, MD on behalf of GWT
GWT-TUD GmbH
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP