| Trial ID: | L3664 |
| Source ID: | NCT01513369
|
| Associated Drug: |
Ferric Carboxymaltose
|
| Title: |
Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
|
| Acronym: |
CLEVER
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Iron Deficiency
|
| Interventions: |
DRUG: ferric carboxymaltose|DRUG: NaCl (0,9%)
|
| Outcome Measures: |
Primary: reduction in HBA1c-levels, reduction of HbA1c from week 1 (baseline) to week 13, 12 weeks | Secondary: improvement of haematological and iron status, Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin, 12 weeks|improvement in quality of life, potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM, 12 weeks|Improvement of metabolic status, measurement of fasting glucose, fructosamine, 12 weeks|reliability of HbA1c-measurements, measurement of HbA1c in week 0; 5 and 13, 12 weeks|improvement in vascular function, Improvement in vascular function on the basis of the biomarker ADMA serum level, 12 weeks|Change in used insulin dosage during study, Change in used insulin dosage during study (via patient diary), 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: GWT-TUD GmbH | Collaborators: Vifor Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
152
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-08
|
| Completion Date: |
2019-04
|
| Results First Posted: |
|
| Last Update Posted: |
2021-02-04
|
| Locations: |
Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude, Herne, Nordrhein-Westfalen, 32545, Germany|Univesitätsklinikum Carl Gustav Carus, Dresden, Sachsen, 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, Hannover, 30625, Germany|Diabetesinstitut Heidelberg, Heidelberg, 69115, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01513369
|
