EUCTR2013-004375-12-DK进行中（未招募）1 期
TODINELI TrialA randomized, double-blinded, single-centre, parallel-group, placebo-controlled, prospective trial of the neuroprotective effect of Liraglutide for treatment of diabetic neuropathy - TODINELI
Center of Mech-Sense0 个研究点开始时间: 2014年2月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1) Habile person of Northern European descent
- •2) Age between 18 to 65 years
- •3) A verified diagnosis of DM type I for minimum 2 years
- •4) Stable DM treatment for minimum 3 months prior to screening
- •5) The participants must be able to read and understand Danish.
- •6) Peripheral diabetic neuropathy ensured by having abnorm nerve conduction velocity
- •7) BMI equal to or above 22
- •8) Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- •9) Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Estimated glomerular filtration rate (s-creatinin/eGFR ) < 60 ml/min/1.37m2
- •2) Calcitonin > 25)
- •3) HbA1c level < 7%
- •4) Patients with any clinically significant laboratory abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- •5) Patients on GLP-1 receptor agonist treatment (exenatide, liraglutide or others) or pramlintide or any DPP-4 inhibitor within 3 months prior to screening.
- •6) Other neurological and/or psychiatric disease
- •7) Treatment of other endocrinological disease except hypothyreosis
- •8) Malignant neoplasms requiring chemotherapy, surgery, radiation or palliative care in the previous 5 years.
- •9) Family or personal history of multiple endocrine neoplasis type 2 (MEN2) or familial medullary thyroid carcinoma
- •10) Personal history of non-familial medullary thyroid carcinoma
- •11) Known abuse of alcohol and/or medicine (Alcohol use in accordance with the recommendations by the Danish Health and Medicines Authority are allowed).
- •12) Known allergy to liraglutide
- •13) Participation in other clinical trials less than 3 months prior to inclusion
- •14) Female patients who are pregnant or lactating, or intend to become pregnant and male patients who intend to father a child during the course of the study.
- •15) In women, a serum pregnancy test will be conducted at baseline based on h-CG in the blood. The investigator will have to ensure that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study medication period. The following methods are considered as safe contraception methods:
- •a. The combined oral contraceptive pill
- •b. Intra uterine device
- •c. Gestagen injection
- •d. Subdermal implantation
- •e. Hormone vaginal ring
- •f. Transdermal plaster
研究者
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