The LIXI trial is aiming to recruit individuals with type 1 diabetes who are using insulin to control their disease. The trial is investigating whether a daily injection of a newly-licenced drug called lixisenatide, taken alongside a person's usual insulin medication can improve blood sugar levels after meals.
- Conditions
- Type 1 diabetes mellitusMedDRA version: 14.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002259-14-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 27
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method