EUCTR2016-003843-12-DK进行中（未招募）1 期
A Single-dose dose escalation trial in a randomised, single-blind, placebo-controlled group-comparison design to investigate the safety and tolerability of XEN-D0501 in 24 patients with diabetes mellitus type 2
PILA PHARMA0 个研究点目标入组 26 人开始时间: 2017年1月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
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. The subject must give his/her signed and dated informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject.
- •2. Diagnosis of type 2 diabetes mellitus
- •3. In treatment with metformin, but no other anti-diabetic drugs
- •4. In treatment with an ACE-inhibitor but no other anti-hypertensive drugs
- •5. HbA1C (glycosylated haemoglobin A1C) 7-9 %
- •6. Age between 30 and 70 years (both inclusive).
- •7. Body mass index (BMI) 27 to 35 kg/m2
- •8. Fasting C-peptide > 600 pmol/l
- •9. Abdominal adiposity, defined waist circumference > 102 cm for male and > 88 cm for
- •female subjects
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator.
- •2. A subject who has a supine blood pressure at screening (including those on antihypertensives),
- •after resting for 5 min, outside the range of 90-140 mmHg systolic or
- •50-90 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeated
- •measurement on a second screening visit shows values within the range, the subject
- •can be included in the trial).
- •3. A subject who is in pharmacological treatment of hypertension if the current treatment
- •includes other than an ACE-inhibitor
- •4. A subject who has a clinically significant abnormal ECG at screening, as judged by
- •the investigator.
- •5. A subject who has participated in any other trials involving investigational products
- •within the 3 months preceding the start of dosing.
- •6. A subject who has donated any blood or plasma in the past month or in excess of 500
- •mL within the 3 months preceding screening.
- •7. A subject who has a significant history of alcoholism or drug/chemical abuse as per
- •investigator’s judgement, or who has a positive result in the urine drug/alcohol screen
- •at screening visit.
- •8. A subject who smokes more than 5 cigarettes, or the equivalent, per day and is unable
- •to refrain from smoking during the in-house periods as determined by the Investigator.
- •9. A subject with mental incapacity or language barriers which preclude adequate
- •understanding or cooperation, who is unwilling to participate in the trial, or who in the
- •opinion of their general practitioner or the Investigator should not participate in the
- •10. Surgery or trauma with significant blood loss within the last 2 months prior to dosing.
- •11. A subject with a history of or presence of cancer, or any clinically significant,
- •respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the
- •exception of diabetes mellitus type 2 and euthyroid struma), haematological,
- •dermatological, venereal, neurological, psychiatric diseases or other major disorders.
- •12. Cardiac problems defined as: decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris and/or acute myocardial infarction within the last 12 months.
- •13. A subject with a clinically significant abnormal haematology or biochemistry tests at
- •screening visit, as judged by the Investigator considering the underlying disease.
- •14. Current treatment with drugs known to interfere with glucose metabolism such as
- •systemic corticoids and monoamine oxidase inhibitors (MAO) inhibitors.
- •15. A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
- •16. Haemoglobin < 6.2 mmol/l, total leukocyte count < 3.0 x 109/l, thrombocytes <100 x 109/l, serum creatinine levels = 126 µmol/l (male) or = 111 µmol/l (female), bilirubin > 3 x ULN, alkaline phosphatase > 2 x ULN, one re-test within a week is permitted.
- •17. Previous participation (randomisation) in this trial.
- •18. Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator and/or sponsor
- •19. Recurrent major hypoglycaemia or hypoglycaemic unawareness, as judged by the Investigator.
- •20. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not usin
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