ISRCTN00290196已完成2 期
The effect of lixisenatide in type 1 diabetes: a randomised controlled trial
niversity of Oxford (UK)0 个研究点目标入组 27 人开始时间: 2014年4月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 08/02/2016:
- •1. Has provided written informed consent
- •2. Type 1 diabetes
- •3. Diabetes duration for at least 12 months
- •4. Age 18-70 years inclusive (upper age limit specified for clinical safety as there is limited experience of using lixisenatide beyond 75 years
- •5. Basal-Bolus insulin regimen
- •6. HbA1c between 7.0% and 10.0% (inclusive)
- •7. 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 may be included at the discretion of the Principal Investigator
- •8. BMI < 35 kg/m2
- •9. 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 <0.01 nmol/l with accompanying glucose >4 mmol/l
- •Original inclusion criteria:
- •1. Has provided written informed consent
- •2. Type 1 diabetes
- •3. Diabetes duration for at least 12 months
- •4. Insulin treatment since the diagnosis of diabetes
- •5. Age 18-65 years (upper age limit specified for clinical safety as there is limited experience of using lixisenatide beyond 65 years)
- •6. Basal-Bolus insulin regimen
- •7. HbA1c between 7.0% and 9.0% (inclusive)
- •8. 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 may be included at the discretion of the Principal Investigator
- •9. BMI < 30 kg/m2
- •10. 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
排除标准
- •1. Type 2 diabetes
- •2. Maturity Onset Diabetes of the Young (MODY)
- •3. Pregnancy or women of childbearing age without adequate contraception
- •4. Women who are breastfeeding
- •5. Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse
- •6. Renal impairment (eGFR = 50 ml/min)
- •7. Abnormal liver function tests (> 1.5 x upper limit of the normal range)
- •8. Have high blood pressure (>180 mmHg systolic or >100 mmHgdiastolic)
- •9. Known ischaemic heart disease or heart failure
- •10. History of stroke
- •11. Patient has received any investigational drug within 30 days prior to screening
- •12. Oral steroid treatment 30 days prior to randomisation
- •13. 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
- •14. Non-English speakers will be excluded due to the nature and complexity of the hypoglycaemic clamp methodology
- •15. Known allergy to the drugs or any of the components
- •16. Severe hypoglycaemia requiring third party intervention on more than one occasion in the preceding 12 months
- •17. (For Part B trial) took part in the lixisenatide prandial dose-finding Part A trial
- •18. Felt to be unsuitable to participate in the trial in the opinion of the Principal Investigator
- •19. Currently taking domperidone, metoclopramide or warfarin
研究者
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