CTRI/2010/091/000063已完成2 期
A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center,Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Eisai LimitedEuropean Knowledge Centre0 个研究点目标入组 750 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects aged between 18 and 75 years old at screening
- •2.Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus, with a diagnosis at least 12 months prior to screening
- •3.Subjects whose glycemic control has been optimized and stable for at least 3 months prior to screening. Optimal glycemic control refers to the best possible diabetic control that an individual subject can attain with usual standards of care. Stable control refers to no dose changes to existing medications for glycemic control (other than insulin) and no medications being initiated for glycemic control in the 3 months prior to screening
- •4.Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria:
- •- Abnormal nerve conduction velocity (NCV) of the sural nerve (less than or equal to 1st percentile, corrected for age; table will provided by the Neurological Core Laboratory in the manual of electrophysiological testing procedures). If recordings are technically acceptable, absent sural nerve responses provide clear evidence of an abnormal response.
- •- Abnormal PMNCV (less than or equal to 1st percentile, corrected for age; table will provided by the Neurological Core Laboratory in the manual of electrophysiological testing procedures). Peroneal responses must be present, with an evoked compound muscle action potential (CMAP) in the extensor digitorum brevis muscle greater than or equal to 500 microvolt. PMNCV must be greater than a value defined as 20% of the lower limit of normal (e.g. if the lower limit of normal is 40 m/sec, PMNCV must be greater than or equal to 32 m/sec). PMNCV will be recorded bilaterally on two separate occasions within 1-21 days of each other during the pre-randomization period; both sets of recordings must fulfill the above criteria.
- •- Decreased/absent ankle reflexes AND/OR decreased distal sensation in the lower limbs
- •- Neuropathy Total Symptom Score-6 (NTSS-6) greater than or equal to 1 (at Visit 1 and at Visit 2)
- •5.Female subjects, who are of non-reproductive potential (greater than or equal to 12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception
- •6.Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.
排除标准
- •1.History of diabetic foot ulcers (Wagner grade greater than or equal to 1) or lower extremity amputation
- •2.Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms (e.g., sequelae of cerebrovascular disease, lumbar radiculopathy, entrapment neuropathy etc)
- •3.Subjects with a history of hypothyroidism or B12/folate deficiency or subjects with a low serum folate, vitamin B12 or elevated thyroid-stimulating hormone at screening, as defined by the central laboratory normal limits range
- •4.History or evidence of drug or alcohol abuse
- •5.History of known or suspected diagnosis of acquired immune deficiency syndrome, or who have tested seropositive for human immunodeficiency virus antibody or antigen previously
- •6.Significant cardiovascular disease such as:
- •oPeripheral arterial occlusive disease (Fontaine Stage greater than or equal to IIa)
- •oClinically significant (in the opinion of the investigator) abnormal 12-lead electrocardiogram (ECG)
- •oNew York Heart Association greater than or equal to class III heart failure
- •7.Significant hepatic disease, e.g.
- •oRepeated alanine aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) > 2x the upper limit of normal at screening or total bilirubin > 1.5x the upper limit of normal at screening
- •oPositive result from hepatitis B or C screening tests or a history of a positive test at screening
- •8.History of hypoglycaemia resulting in loss of consciousness, diabetic ketoacidosis or hyperglycaemic hyperosmolar non-ketotic coma in the 3 months prior to screening
- •9.Morbid obesity (body mass index [BMI]>40 kg/m2) at screening
- •10.Calculated creatinine clearance <50 mL/min at screening (see Appendix 2)
- •11.History of carcinoma within 5 years prior to screening, with the exception of basal cell carcinoma
- •12.Current major depressive disorder, bipolar disorder or a past history of suicide attempt or deliberate self-harm
- •13.Subjects who have received an investigational medicinal product within 3 months prior to the screening visit or subjects who have participated in a previous study with ranirestat
- •14.Clinically significant illness (e.g. unstable pulmonary, hematologic, renal, neurological or psychiatric disease etc.) which, in the opinion of the investigator, would compromise a subjects suitability to participate in the study for reasons of safety or would confound the efficacy assessments
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