Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
CLEVER
Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency
2 other identifiers
interventional
152
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started Aug 2012
Longer than P75 for phase_3 type-2-diabetes-mellitus
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedFebruary 4, 2021
February 1, 2021
6.2 years
January 3, 2012
February 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction in HBA1c-levels
reduction of HbA1c from week 1 (baseline) to week 13
12 weeks
Secondary Outcomes (6)
improvement of haematological and iron status
12 weeks
improvement in quality of life
12 weeks
Improvement of metabolic status
12 weeks
reliability of HbA1c-measurements
12 weeks
improvement in vascular function
12 weeks
- +1 more secondary outcomes
Study Arms (2)
ferric carboxymaltose
EXPERIMENTALDose: 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
NaCl (0,9%)
PLACEBO COMPARATORDuration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
Interventions
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
Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
Eligibility Criteria
You may not qualify if:
- 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.
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GWT-TUD GmbHlead
- Vifor Pharmacollaborator
Study Sites (6)
Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude
Herne, North Rhine-Westphalia, 32545, Germany
Univesitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum
Bad Oeynhausen, 32545, Germany
Studienzentrum Professor Hanefeld Abakus Büropark
Dresden, 01307, Germany
Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC
Hanover, 30625, Germany
Diabetesinstitut Heidelberg
Heidelberg, 69115, Germany
Related Publications (1)
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.
PMID: 29134606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Schindler, MD
on behalf of GWT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 20, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2018
Study Completion
April 1, 2019
Last Updated
February 4, 2021
Record last verified: 2021-02