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

NCT ID: NCT01513369

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2019-04-30

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.

Conditions

Type 2 Diabetes Mellitus; Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

ferric carboxymaltose

Intervention Type: DRUG

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%)

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

Group Type: PLACEBO_COMPARATOR

NaCl (0,9%)

Intervention Type: DRUG

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

Interventions

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 Type: 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

Intervention Type: DRUG

Other Intervention Names

Ferinject (marketing authorization number: 66227.00.00)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

GWT-TUD GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Schindler, MD

Role: PRINCIPAL_INVESTIGATOR

on behalf of GWT

Locations

Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude

Herne, North Rhine-Westphalia, Germany

Univesitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum

Bad Oeynhausen, , Germany

Studienzentrum Professor Hanefeld Abakus Büropark

Dresden, , Germany

Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC

Hanover, , Germany

Diabetesinstitut Heidelberg

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29134606 (View on PubMed)

Other Identifiers

2011-005224-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLEVER-2011

Identifier Type: -

Identifier Source: org_study_id