The effect of lixisenatide in type 1 diabetes

Phase 2

Completed

• Conditions: Topic: Diabetes; Subtopic: Type 1; Disease: Diabetic Control; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN00290196
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-03
• Study Completion: 2016-06-30
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ixisenatide effect on 3 hr post-prandial Continuous Glucose Monitoring readings compared to placebo; Timepoint(s): Part B trial.

Secondary Outcome Measures

Name	Time	Method
HbA1c, insulin dose and glucagon change after standard mixed meal and insulin-induced hypoglycaemia; Timepoint(s): Following 4 weeks' compliance with study medication.