To investigate whether treatment with the GLP-1 receptor agonist exenatide improves the perception of hypoglycaemia in people with type 1 diabetes with impaired awareness of hypoglycaemia

Phase 1

• Conditions: Type 1 diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-000790-21-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-20
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Type 1 diabetes, disease duration >1 year
• Age >18 years, <70 years
• Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
• Impaired hypoglycaemic awareness as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
• Glycated haemoglobin (HbA1c) =42 mmol/mol (6%) and =75 mmol/mol (9.0%)
• Ability to provide informed consent
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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Treatment with incretin-based therapy (DPP-IV inhibitors or GLP-1RAs)
• Known intolerance to GLP-1RAs (including allergy)
• Treatment with glucose-modefying or immune-modefying agents, e.g. prednisolon
• History of cardiovascular disease or laser coagulation for proliferative retinopathy (past 6 months)
• Proliferative retinopathy
• Symptomatic diabetic neuropathy
• Diabetic nephropathy as reflected by albumin-creatinin ratio >30 mmol/mg or MDRD <60 ml/min/1.73 m2
• Known heart failure
• History of pancreatitis (acute or chronic) or pancreatic cancer
• Body-mass index >40 kg/m2
• Blood pressure >160/90 mmHg
• Use of premixed insulin or of long-acting insulin alone
• Total daily insulin dose requirements <20 units unless on pump treatment
• Pregnancy or unwillingness to undertake measures for birth control

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of treatment with the GLP-1ra exenatide on the awareness of and counterregulatory hormone responses to hypoglycaemia in people with type 1 diabetes and impaired hypoglycaemic awareness <br>;Secondary Objective: To investigate the effect of treatment with the GLP-1ra exenatide on the glycaemic recovery from hypoglycaemia and the post-hypoglycaemic glucose excursion in people with type 1 diabetes and impaired hypoglycaemic awareness;Primary end point(s): Maximal symptom score in response to the hyperinsulinemic hypoglycaemic glucose clamp experiment;Timepoint(s) of evaluation of this end point: During hypoglycaemic glucose clamp after 6 weeks