Liraglutide Treatment to Patients With Severe Renal Insufficiency

Sponsor
Bo Feldt-Rasmussen
Study ID
NCT01394341
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Daily sc. injection, individual dosage

Study Details

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

Key Dates

Start date
Sep 30, 2011
Status verified
Oct 2013
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: T2D, Dialysis, Liraglutide
    Daily liraglutide treatment Chronic dialysis treatment
  • Placebo Comparator: T2D, Dialysis, Placebo
    Daily placebo Chronic dialysis treatment
  • Active Comparator: T2D, Normal kidney function, Liraglutide
    Daily Liraglutide treatment Normal kidney function
  • Placebo Comparator: T2D, Normal kidney function, Placebo
    Daily placebo treatment Normal kidney function

Primary Outcome Measure

Plasma liraglutide concentration (pmol/L) [ Time Frame: 12 weeks ]

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