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Liraglutide Treatment to Patients With Severe Renal Insufficiency

NCT01394341 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-10-09

No results posted yet for this study

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

Interventions

DRUG

Liraglutide

Daily sc. injection, individual dosage

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • The GCP unit at Copenhagen University Hospital

    collaborator UNKNOWN

  • Bo Feldt-Rasmussen

    lead OTHER

Principal Investigators

  • Bo Feldt-Rasmussen, Prof, DMSc · Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet

  • Thomas Idorn, MD · Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394341 on ClinicalTrials.gov