NCT01394341

Liraglutide Treatment to Patients With Severe Renal Insufficiency

Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bo Feldt-Rasmussen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin. The novel and original aspect of this investigator-initiated study is the focus on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients with severely reduced kidney function. At present there is virtually no knowledge of the physiology and clinical implications of the role of incretin hormones and incretin-based therapy in this group of diabetic patients.The aim of the study is to establish an evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and reducing risk factors of cardiovascular disease

Conditions

• Type 2 Diabetes Mellitus
• End-stage Renal Disease

Interventions

Type	Name	Description
DRUG	Liraglutide	Daily sc. injection, individual dosage

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-07-14
• Last updated: 2013-10-09

Locations

3 sites across 1 country: Denmark