Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01513369
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2012-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2012-01-16', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in HBA1c-levels', 'timeFrame': '12 weeks', 'description': 'reduction of HbA1c from week 1 (baseline) to week 13'}], 'secondaryOutcomes': [{'measure': 'improvement of haematological and iron status', 'timeFrame': '12 weeks', 'description': 'Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin'}, {'measure': 'improvement in quality of life', 'timeFrame': '12 weeks', 'description': 'potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM'}, {'measure': 'Improvement of metabolic status', 'timeFrame': '12 weeks', 'description': 'measurement of fasting glucose, fructosamine'}, {'measure': 'reliability of HbA1c-measurements', 'timeFrame': '12 weeks', 'description': 'measurement of HbA1c in week 0; 5 and 13'}, {'measure': 'improvement in vascular function', 'timeFrame': '12 weeks', 'description': 'Improvement in vascular function on the basis of the biomarker ADMA serum level'}, {'measure': 'Change in used insulin dosage during study', 'timeFrame': '12 weeks', 'description': 'Change in used insulin dosage during study (via patient diary)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'iron deficiency'], 'conditions': ['Type 2 Diabetes Mellitus', 'Iron Deficiency']}, 'referencesModule': {'references': [{'pmid': '29134606', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'T2DM patients with diagnosis of ID defined as follows:\n\n* 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\\]\n* HbA1c: ≥ 6.5 to \\< 8.5 %\n* Age \\> 18 years\n* Written informed consent has been obtained.\n\nExclusion Criteria:\n\n* Continuous subcutaneous insulin infusion (CSII)\n* thalassaemia\n* Hb \\> 15 g/dL (\\> 9,31 mmol/L)\n* Change of HbA1c of more than ±0,3 % within the last 3 months.\n* known sensitivity to ferric carboxymaltose\n* history of acquired iron overload\n* History of erythropoietin stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 12 weeks prior to randomisation\n* 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.\n* Body weight ≤ 40 kg\n* CRP \\> 15 mg/L\n* 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).\n* Subjects with known hepatitis B surface antigen positivity and/or Hepatitis C virus ribonucleic acid positivity.\n* Vitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion.\n* Subjects with known seropositivity to human immunodeficiency virus.\n* Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.\n* Currently receiving systemic chemotherapy and/or radiotherapy.\n* Renal dialysis (previous, current or planned within the next 6 months).\n* Renal function GFR \\< 30 mL/min/ 1.73m2 (severe)\n* 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.\n* Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomisation.\n* 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.\n* Patients with a polyneuropathy without ischemia.\n* Subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.\n* 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.\n* Participation in other interventional trials\n* Female subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.\n* Failure to use highly-effective contraceptive methods\n* Persons with any kind of dependency on the investigator or employed by the sponsor or investigator'}, 'identificationModule': {'nctId': 'NCT01513369', 'acronym': 'CLEVER', 'briefTitle': 'Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'GWT-TUD GmbH'}, 'officialTitle': 'Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency', 'orgStudyIdInfo': {'id': 'CLEVER-2011'}, 'secondaryIdInfos': [{'id': '2011-005224-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ferric carboxymaltose', 'description': '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', 'interventionNames': ['Drug: ferric carboxymaltose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl (0,9%)', 'description': 'Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous', 'interventionNames': ['Drug: NaCl (0,9%)']}], 'interventions': [{'name': 'ferric carboxymaltose', 'type': 'DRUG', 'otherNames': ['Ferinject (marketing authorization number: 66227.00.00)'], 'description': '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', 'armGroupLabels': ['ferric carboxymaltose']}, {'name': 'NaCl (0,9%)', 'type': 'DRUG', 'description': 'Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous', 'armGroupLabels': ['NaCl (0,9%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Herne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Univesitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Studienzentrum Professor Hanefeld Abakus Büropark', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Diabetesinstitut Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Christoph Schindler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'on behalf of GWT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GWT-TUD GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vifor Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}