NCT02735031

Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes

Effect of the GLP-1 Receptor Agonist Exenatide on Impaired Hypoglycaemic Awareness in Type 1 Diabetes

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the end-result of a process of habituation to recurrent hypoglycemia that is potentially reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the GLP-1RA, exenatide, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.

Conditions

• Diabetes Mellitus, Type 1
• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Exenatide	6 weeks treatment with exenatide on top of insulin treatment
DRUG	Placebo	6 weeks treatment with placebo on top of insulin treatment

Timeline

• Start date: 2017-02-21
• Primary completion: 2018-03-28
• Completion: 2018-04-09
• First posted: 2016-04-12
• Last updated: 2018-04-12

Locations

1 site across 1 country: Netherlands