Clinical trial NCT01513369: Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
Official title: Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Iron Deficiency
Keywords: Diabetes
iron deficiency
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2012-01-20
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: reduction in HBA1c-levels
timeFrame: 12 weeks
Secondary outcomes:
measure: improvement of haematological and iron status
timeFrame: 12 weeks
measure: improvement in quality of life
timeFrame: 12 weeks
measure: Improvement of metabolic status
timeFrame: 12 weeks
measure: reliability of HbA1c-measurements
timeFrame: 12 weeks
measure: improvement in vascular function
timeFrame: 12 weeks
measure: Change in used insulin dosage during study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Univesitätsklinikum Carl Gustav Carus
state: Sachsen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum
city: Dresden
country: Germany
facility: Studienzentrum Professor Hanefeld Abakus Büropark
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC
city: Heidelberg
country: Germany
facility: Diabetesinstitut Heidelberg
Study officials:
affiliation: on behalf of GWT
name: Christoph Schindler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schindler C, Birkenfeld AL, Hanefeld M, Schatz U, Kohler C, Gruneberg M, Tschope D, Bluher M, Hasslacher C, Bornstein SR. Intravenous Ferric Carboxymaltose in Patients with Type 2 Diabetes Mellitus and Iron Deficiency: CLEVER Trial Study Design and Protocol. Diabetes Ther. 2018 Feb;9(1):37-47. doi: 10.1007/s13300-017-0330-z. Epub 2017 Nov 13.