CLEVER: Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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 Names:
|
| 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 |
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
|
Outcome Measures
Primary Outcome Measures
- reduction in HBA1c-levels [12 weeks]
reduction of HbA1c from week 1 (baseline) to week 13
Secondary Outcome Measures
- improvement of haematological and iron status [12 weeks]
Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin
- improvement in quality of life [12 weeks]
potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM
- Improvement of metabolic status [12 weeks]
measurement of fasting glucose, fructosamine
- reliability of HbA1c-measurements [12 weeks]
measurement of HbA1c in week 0; 5 and 13
- improvement in vascular function [12 weeks]
Improvement in vascular function on the basis of the biomarker ADMA serum level
- Change in used insulin dosage during study [12 weeks]
Change in used insulin dosage during study (via patient diary)
Eligibility Criteria
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]
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HbA1c: ≥ 6.5 to < 8.5 %
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Age > 18 years
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Written informed consent has been obtained.
Exclusion Criteria:
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Continuous subcutaneous insulin infusion (CSII)
-
thalassaemia
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Hb > 15 g/dL (> 9,31 mmol/L)
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Change of HbA1c of more than ±0,3 % within the last 3 months.
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known sensitivity to ferric carboxymaltose
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history of acquired iron overload
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History of erythropoietin stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 12 weeks prior to randomisation
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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.
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Body weight ≤ 40 kg
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CRP > 15 mg/L
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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).
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Subjects with known hepatitis B surface antigen positivity and/or Hepatitis C virus ribonucleic acid positivity.
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Vitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion.
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Subjects with known seropositivity to human immunodeficiency virus.
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Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.
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Currently receiving systemic chemotherapy and/or radiotherapy.
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Renal dialysis (previous, current or planned within the next 6 months).
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Renal function GFR < 30 mL/min/ 1.73m2 (severe)
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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.
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Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomisation.
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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.
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Patients with a polyneuropathy without ischemia.
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Subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.
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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.
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Participation in other interventional trials
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Female subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.
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Failure to use highly-effective contraceptive methods
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Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude | Herne | Nordrhein-Westfalen | Germany | 32545 |
| 2 | Univesitätsklinikum Carl Gustav Carus | Dresden | Sachsen | Germany | 01307 |
| 3 | Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum | Bad Oeynhausen | Germany | 32545 | |
| 4 | Studienzentrum Professor Hanefeld Abakus Büropark | Dresden | Germany | 01307 | |
| 5 | Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC | Hannover | Germany | 30625 | |
| 6 | Diabetesinstitut Heidelberg | Heidelberg | Germany | 69115 |
Sponsors and Collaborators
- GWT-TUD GmbH
- Vifor Pharma
Investigators
- Principal Investigator: Christoph Schindler, MD, on behalf of GWT
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLEVER-2011
- 2011-005224-18