EUCTR2017-003054-16-DE进行中（未招募）1 期
Randomized double-blind, placebo-controlled parallel group study over 12 months to assess the effects of treatment with benfotiamine on morphometric, neurophysiological, and clinical measures in type 2 diabetes patients with mild to moderate symptomatic polyneuropathy - BOND Study - BOND Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed consent signed and dated
- •Diabetes mellitus type 2 according to the American Diabetes Association criteria (2017), lasting =1 year
- •Stable diabetes metabolism, defined as no metabolic decompensation within the last 3 months (severe hypoglycemia with unconsciousness, ketoacidosis)
- •According to the investigator’s opinion no further optimizing potential in diabetic control
- •Age: =18 years
- •Neuropathic symptoms =6 months
- •Presence of mild to moderate diabetic sensorimotor polyneuropathy (DSPN) with Neuropathy Disability Score (NDS) 3-8 points confirmed by at least one of the following: reduced sural sensory nerve conduction velocity (SNCV), sural sensory nerve action potential (SNAP), peroneal motor nerve conduction velocity (MNCV), tibial MNCV
- •Measurable sural SNCV, peroneal MNCV or tibial MNCV above detection limit
- •CNFL <1SD below the mean of control subjects
- •At least 1 palpable pulse of posterior tibial artery or dorsal artery on each side of the foot
- •Stable diabetes medication without optimizing potential
- •Stable insulin dose for insulin-dependent patients within the last 3 months
- •HbA 1c <9.5%
- •Acceptable contraceptive measures with female patients in childbearing potential
- •Ability to meet the study center visits for the study Duration
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Subjects with secondary forms of diabetes such as due to pancreatitis
- •Contraindications, known allergy, or hypersensitivity to benfotiamine or other ingredients of the study medication or local anesthetics
- •Neuropathy of any cause other than diabetes which might interfere with neurological assessment
- •Severe pain other than of neuropathic origin that might impair the assessment of neuropathic pain
- •Diseases with mixed pain components
- •Pain level >9 over 24 h on a numerical 11-Point rating scale
- •Proximal asymmetric neuropathy or neuropathic symptoms of the trunk or proximal lower limbs
- •Foot ulcer or infection
- •Currently active or history of alcohol abuse (defined as an intake of more than 24 units of alcohol per week; one unit of alcohol equals approximately 250 ml of beer, 100 ml of wine or 35 ml of spirits) or drug addiction (including soft drugs like cannabis products)
- •Peripheral arterial occlusive disease Fontaine stage II-IV
- •Renal failure (serum creatinine > (above) 120 µmol/l or 1.4 mg/dl)
- •As judged by the investigator, serious and/or unstable coronary heart disease (unstable angina, myocardial infarction within the preceding 6 months), congestive heart failure of New York Heart Association Class III or worse, uncontrolled hypertension, history of congenital QT-syndrome within family, history of stroke (within the preceding 6 months)
- •Uncontrolled high blood pressure (DBP >95 mmHg and/or SBP >160 mmHg), unless clearly documented to be white-coat hypertension
- •Clinical or laboratory evidence of hepatic dysfunction or disease; laboratory evidence defined as any of the following parameters: alkaline phosphatase, ALT, AST or bilirubin >3x ULN, except for a mild rise in bilirubin considered to be due to Gilbert’s condition.
- •Generalized immune diseases (e.g. HIV-positive, autoimmune diseases, connective tissue diseases)
- •Endocrine diseases like hyper- or hypothyroidism
- •Treatment, lasting at least 5 days or longer, with alpha-lipoic acid, B-vitamins, evening primrose oil, or deproteinized hemoderivates of calf blood, containing low-molecular weight compounds of up to 5.000 Da or with other substances with interaction to the study product (e.g. 5-fluorouracil) or affecting study endpoints within the last 3 months before screening, except for daily intake of B-vitamins amounting to less than 1500 % of the recommended daily allowance (RDA) lasting until one month prior to screening.
- •Treatment with cutaneous electrical nerve stimulation, muscle stimulation or acupuncture within the last month
- •Treatment of neuropathic pain with antidepressants, anticonvulsants, sodium channel blockers, opioids, neuroleptics, and capsaicin 8% patch within the last 3 months prior to screening , except for a monotherapy with Gabapentin, Pregabalin or Duloxetin without relevant dose change within the last 2 months prior to screening and during the study.
- •Mental, psychiatric or other conditions compromising data collection and understanding of written or oral instructions during the study
- •Present or previous chronic alcohol abuse and/or abuse of other drugs
- •Pregnant women or nursing mothers
- •Participation in another clinical trial study within the last 3 months
- •Ability and willingness to abstain from alcohol and from engaging in strenuous physical activity from 24 hours prior to each visit until discharge from the unit
- •Blood donation within the last 3 months before or during the study
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