EUCTR2019-002318-37-DE进行中（未招募）1 期
A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients with Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
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
- 20
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
- •-Male or female subject with diabetes mellitus type 1 for at least 1 year.
- •-Age between 18 and 64 years, both inclusive.
- •-Body Mass Index (BMI) between 18.5 and 33.0 kg/m^2, both inclusive.
- •-HbA1c <= 9.0%.
- •-Fasting negative C-peptide (<= 0.30 nmol/L).
- •-Currently on stable CSII for at least 3 months prior to inclusion into the trial, with a total daily insulin dose of >0.4 and <=1.5 U/kg/day.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Previous participation in this trial. Participation is defined as randomised.
- •-Known allergies to adhesives, NSAIDs (e.g. Meloxicam), insulin lispro, insulin glulisine (Apidra), related compounds, or any components of the IMPs used in this trial.
- •-Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
- •-Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension).
- •-Symptoms of arterial hypotension
- •-Heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
- •-Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption.
- •-AST and/or ALT > 2 times the upper limit of normal.
- •-Elevated serum creatinine values above the upper limit of normal.
- •-More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
- •-Hypoglycaemic unawareness as judged by the Investigator.
- •-Hospitalisation for diabetic ketoacidosis during the previous 6 months.
- •-A positive result in the alcohol and/or urine drug screen at the screening visit.
- •-Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period.
- •-Intended use of systemic NSAIDs during the study.
- •-Blood donation or blood loss of more than 500 mL within the last month.
- •-If female, pregnancy or breast-feeding
- •-Women of childbearing potential who are not using a highly effective contraceptive method until 1 month after last dosing.
- •-Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 1 month after last dosing.
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