NCT01513369已完成3 期
Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- reduction in HBA1c-levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
研究组 & 干预措施
ferric carboxymaltose
Experimental
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
干预措施: ferric carboxymaltose (Drug)
NaCl (0,9%)
Placebo Comparator
Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
干预措施: NaCl (0,9%) (Drug)
结局指标
主要结局
reduction in HBA1c-levels
时间窗: 12 weeks
reduction of HbA1c from week 1 (baseline) to week 13
次要结局
- improvement of haematological and iron status(12 weeks)
- improvement in quality of life(12 weeks)
- Improvement of metabolic status(12 weeks)
- reliability of HbA1c-measurements(12 weeks)
- improvement in vascular function(12 weeks)
- Change in used insulin dosage during study(12 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
撤回
4 期
Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection FractionHeart Failure With Normal Ejection FractionIron-deficiencyNCT05477498Cantonal Hosptal, Baselland
已完成
3 期
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant WomenAnaemiaNCT01131624Vifor Pharma252
招募中
Unknown
Effect Of oral Iron therapy(tab.Fe(iron-200) on HbA1c(glycosylated hemoglobin) among Type 2 diabetes mellitus having iron deficiency anemia at tertiary care centerCTRI/2023/04/052130Government Medical college and Sir T hospital Bhavnagar
Unknown
4 期
Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?B12 Deficiency AnemiaIron Deficiency AnemiaNCT04627181Christian Medical College, Vellore, India100
进行中（未招募）
不适用
Intravenöse Eisencarboxymaltose-Applikation zur Verbesserung der metabolischen Parameter und der Gefäßfunktion bei Diabetes mellitus Typ 2-Patienten für 12 Wochen (Clever-Studie)patients with diabetes mellitus type 2 and iron deficiencyEUCTR2011-005224-18-DEGWT-TUD GmbH