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Type 2 Diabetes MellitusPhase 3CLEVERNCT01513369

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

A Phase 3 study testing ferric carboxymaltose and NaCl (0,9%) in people with Type 2 Diabetes Mellitus and Iron Deficiency, run by GWT-TUD GmbH at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus, Iron Deficiency
What is being tested?
ferric carboxymaltose and NaCl (0,9%)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
6 sitesGermany
Study dates
Aug 2012to Apr 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum

    Bad Oeynhausen, 32545

  • Univesitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

  • Studienzentrum Professor Hanefeld Abakus Büropark

    Dresden, 01307

  • Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC

    Hanover, 30625

  • Diabetesinstitut Heidelberg

    Heidelberg, 69115

  • Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude

    Herne, North Rhine-Westphalia, 32545

Other trials in Germany

About this study

Official title: 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.

Being tested
ferric carboxymaltose, NaCl (0,9%)
Keywords
Diabetes, iron deficiency
Medical subject headings
Diabetes Mellitus, Type 2, Iron Deficiencies, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ferric carboxymaltoseDrug

    Also called Ferinject (marketing authorization number: 66227.00.00)

    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

  • NaCl (0,9%)Drug

    Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous

Study groups in NCT01513369
Study groupRoleWhat they receive
ferric carboxymaltoseExperimentalDose: 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
Receives: Drug: ferric carboxymaltose
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
Receives: Drug: NaCl (0,9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. reduction in HBA1c-levels

    reduction of HbA1c from week 1 (baseline) to week 13

    Measured: 12 weeks

Secondary outcomes (6)

  1. improvement of haematological and iron status

    Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin

    Measured: 12 weeks

  2. improvement in quality of life

    potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM

    Measured: 12 weeks

  3. Improvement of metabolic status

    measurement of fasting glucose, fructosamine

    Measured: 12 weeks

  4. reliability of HbA1c-measurements

    measurement of HbA1c in week 0; 5 and 13

    Measured: 12 weeks

  5. improvement in vascular function

    Improvement in vascular function on the basis of the biomarker ADMA serum level

    Measured: 12 weeks

  6. Change in used insulin dosage during study

    Change in used insulin dosage during study (via patient diary)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionOct 2018
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513369
Sponsor's protocol ID
CLEVER-2011
Other IDs
2011-005224-18
Acronym
CLEVER
Status last verified
Feb 2021
First submitted
3 Jan 2012
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29134606

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ferric carboxymaltose and NaCl (0,9%) in people with Type 2 Diabetes Mellitus and Iron Deficiency, run by GWT-TUD GmbH at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reduction in HBA1c-levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513369, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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