Liraglutide Treatment to Patients With Severe Renal Insufficiency

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; End-stage Renal Disease
• Interventions: Drug: Liraglutide

• Registration Number: NCT01394341
• Lead Sponsor: Bo Feldt-Rasmussen

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Study Start: 2011-09
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2D, Dialysis, Liraglutide	Liraglutide	Daily liraglutide treatment Chronic dialysis treatment
T2D, Dialysis, Placebo	Liraglutide	Daily placebo Chronic dialysis treatment
T2D, Normal kidney function, Liraglutide	Liraglutide	Daily Liraglutide treatment Normal kidney function
T2D, Normal kidney function, Placebo	Liraglutide	Daily placebo treatment Normal kidney function

Primary Outcome Measures

Name	Time	Method
Plasma liraglutide concentration (pmol/L)	12 weeks	Plasma liraglutide concentration evaluated over time during continuous intervention

Secondary Outcome Measures

Name	Time	Method
Pancreatic beta-cell function	12 weeks	Pancreatic beta-cell function evaluated from insulin- and C-peptide-secretion during a standard meal test 3 times during the intervention period.
Hypoglycaemia; minor or major	12 weeks	Number of hypoglycaemic episodes during intervention. Minor (blood glucose \<3.1 mmol/L, no need for assistance). Major (blood glucose \<3.1 mmol/L, assistance from third person required)
Glycaemic control	12 weeka	Glycaemic control evaluated from 3 daily measurements of blood glucose, from 4 periods of 24-hour tissue glucose measurements (5 days each) and from HbA1c during the intervention period.
Cardiovascular risk factors (lipids and blood pressure)	12 weeks	Blood pressure will be evaluated at each visit and lipid profile (HDL, LDL, total cholesterol and triglyceride) 3 times during the intervention period.

Trial Locations

Locations (3)

Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen Ø, Copenhagen, Denmark

Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen Ø, Copenhagen, Denmark

Department of Internal Medicine H, Hillerød Hospital; 🇩🇰 Hillerød, Denmark