EUCTR2013-002259-14-GB进行中（未招募）1 期
The effect of lixisenatide in type 1 diabetes - The LIXI study
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
- 27
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
入选标准
- •The following inclusion criteria apply to both Part A and B studies:
- •The patient may enter the study if ALL the following criteria apply:
- •Has provided written informed consent
- •Type 1 diabetes
- •Diabetes duration for at least 12 months
- •Insulin treatment since the diagnosis of diabetes
- •Age 18-65 years (upper age limit specified for clinical safety as there is limited experience of using lixisenatide beyond 65 years)
- •Basal-Bolus insulin regimen
- •HbA1c between 7.0% and 9.0% (inclusive)
- •Stable insulin dose (within 20%) over 3 months prior to recruitment. Patients on low doses of insulin, who have had a change of insulin dose by >20% over the preceding 3 months maybe included at the discretion of the Principal Investigator.
- •BMI < 27 kg/m2
- •For the C-peptide positive group:
- •Random or fasting C-peptide = 0.1 nmol/l
- •If clinically indicated, screen negative for mutations in HNF1A, HNF4A or GCK genes (indicative of MODY, maturity onset diabetes of the young)
- •For the C-Peptide negative group:
- •Random or fasting C-peptide <0.02 nmol/l with accompanying glucose >4 mmol/l
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The following inclusion criteria apply to both Part A and B studies:
- •The patient may not enter the study if ANY of the following apply:
- •Type 2 diabetes
- •Maturity Onset Diabetes of the Young (MODY)
- •Pregnancy or women of childbearing age without adequate contraception
- •Women who are breast-feeding
- •Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse
- •Renal impairment (eGFR = 50 ml/min)
- •Abnormal liver function tests (> 1.5 x upper limit of the normal range)
- •Have high blood pressure (>180 mmHg systolic or >100 mmHg diastolic)
- •Known ischaemic heart disease or heart failure
- •History of stroke
- •Patient has received any investigational drug within 30 days prior to screening
- •Oral steroid treatment 30 days prior to randomisation
- •Known malignancy or any other condition or circumstance, which, in the opinion of the investigator, would affect the patient’s ability to participate in the protocol
- •Non-English speakers will be excluded due to the nature and complexity of the hypoglycaemic clamp methodology
- •Known allergy to the drugs or any of the components
- •Severe hypoglycaemia requiring 3rd party intervention on more than one occasion in the preceding 12 months
- •Felt to be unsuitable to participate in the trial in the opinion of the Principal Investigator
- •Currently taking domperidone, metoclopramide or warfarin
- •The following criterion applies to Part B study only:
- •(For Part B study), took part in the lixisenatide prandial dose finding Part A study
研究者
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