EUCTR2010-022513-26-DE进行中（未招募）不适用
Randomised, single-blind, placebo controlled, four-period four-treatment cross-over design, proof of concept study to compare the pharmacodynamic, safety and pharmacokinetics of one single administration of SKP-1052 versus immediate-release terbutaline and placebo tablets in stable Type 1 Diabetes Mellitus Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Clinical diagnosis of Type 1 DM and daily use of insulin therapy for at least one year.
- •2.Male or female subjects, aged between 18 and 50 years inclusive.
- •3.HbA1c <8.5% at screening.
- •4.Patients on insulin pumps or on a multiple basal-bolus regime with the basal insulin given once or twice daily. Basal long lasting analogue with a bolus insulin pre-meal 3 times a day or premixed insulins when one dose is given at bedtime for at least 1 month and not anticipating a change prior to the subject‘s completion of the study.
- •5.Normal values for thyroid-stimulating hormone (TSH), FT3 and FT4.
- •6.Subjects must be able to read, understand and sign the informed consent.
- •7.Subjects must be willing and able to comply with study requirements.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Untreated proliferative retinopathy and/or nephropathy with a serum creatinine concentration greater than upper limit of normal at screening.
- •2.Known coronary, cerebral or peripheral vascular disease, Hypertrophic Obstructive Cardio -Myopathy (HOCM) (previously called idiopathic hypertrophic subaortic stenosis), tachycardia, tachyarrhythmia, uncontrolled hypertension and /or autonomic neuropathy dysfunction.
- •3.Patients with active chest pain, shortness of breath and fatigue on exertion within the last 12 months.
- •4.Clinically significant abnormal safety or laboratory (hematology, biochemistry, urinalysis) screening tests as judged by the Investigator.
- •5.Female subjects of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
- •Male subjects who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods [adequate contraceptive measures include that the subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%)].
- •6.Presence of a significant medical disorder (including epilepsy, or any other cause of seizures, psychiatric, sleep or behavioural disorders) that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- •7.Severe hypoglycaemia resulting in seizure or experienced loss of consciousness in the previous 3 months.
- •8.Known hypersensitivity to terbutaline.
- •9.Asthma which has been medically treated within 6 months before screening.
- •10.Treatment with systemic or inhaled corticosteroids in the last 3 months.
- •11.Active infection (if at the time of the scheduled visit an infection is present, the visit will be deferred).
- •12.Subjects with a history of HIV, hepatitis B or hepatitis C.
- •13.Current treatment with oral and topical (eye) B-blockers and use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- •14.Treatment with ephedrine, phenylephrine, phenylpropanolamine, or pseudoephedrine 48 hours prior to the visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred).
- •15.Anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organised sport).
- •16.Significant blood loss (more than 500 mL) within the last 3 months prior to screening.
- •17.Significant history of alcoholism or drug/chemical abuse or positive result alcohol breath test at screening visit.
- •18.Participated in another investigational study where the study drug was received within 90 days prior to the Screening visit.
研究者
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