NCT02092896

Liraglutide as add-on to Insulin in Type 1 Diabetes

Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

Conditions

• Diabetes
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Liraglutide	Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
DRUG	Placebo	Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
DRUG	Liraglutide	Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
DRUG	Placebo	Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-03-20
• Last updated: 2015-04-01

Locations

1 site across 1 country: Denmark