NCT02020629

Study on Lixisenatide and Counterregulation to Hypoglycemia

Effect of Lixisenatide on Glucagon Secretion During Hypoglycemia in Patients With Insulin-treated Type 2 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In hypoglycemia, there is a counterregulation to restore glucose levels. An important part of this counterregulation is the release of the hormone glucagon. Since the GLP-1 receptor agonist lixisenatide has been shown to be associated with a low risk of hypoglycemia, this study examines whether lixisenatide affects the glucagon response to hypoglycemia.

Detailed description

The study is a single-center, randomized, placebo-controlled study with a cross-over design and examines the glucagon response during a hyperinsulinemic hypoglycemic phase after a 6-week treatment with lixisenatide (or placebo) as add-on to basal insulin and metformin. The hypothesis of the study is that the glucagon counterregulation to hypoglycemia in patients treated with lixisenatide and basal insulin is not lower than in patients treated with basal insulin.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Lixisenatide	Lixisenatide is given for 6 weeks whereafter a hypoglycemia clamp is undertaken

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-08-01
• Completion: 2015-08-01
• First posted: 2013-12-25
• Last updated: 2015-12-15

Locations

1 site across 1 country: Sweden