The effect of liraglutide in patients with prediabetes and kidney failure

Conditions: Prediabetes and dialysis dependent end-stage renal disease
MedDRA version: 17.0Level: LLTClassification code 10014646Term: End stage renal disease (ESRD)System Organ Class: 100000004857
MedDRA version: 17.0Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861
MedDRA version: 17.0Level: LLTClassification code 10012347Term: Dependence on renal dialysisSystem Organ Class: 100000004869
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-001778-32-DK

Lead Sponsor: Bo Feldt-Rasmussen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Male or female; age: 18 - 85 years
•End-stage renal diasease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)
•Impaired glucose tolerance (2h plasma glucose = 7,8 and < 11.1 mmol/l following a 75g-OGTT) and/or impaired fasting glucose (fasting plasma glucose = 6.1 and < 7.0 mmol/l) evaluated at the screening visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)
•Chronic pancreatitis / previous acute pancreatitis
•Known or suspected hypersensitivity to trial product(s) or related products
•Treatment with oral glucocorticoids, calcineurin inhibitors or incretin-based therapy which in the Investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening
•Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the investigator’s opinion could interfere with the results of the trial
•Clinical suspicion of cardiac disease currently investigated
•Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
•Body mass index (BMI) <20 kg/m2 and/or >50 kg/m2
•Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods*
•Impaired liver function (transaminases > two times upper reference levels)
•The receipt of any investigational product 90 days prior to this trial
•Known or suspected abuse of alcohol or narcotics
•Screening calcitonin = 50 ng/l
•Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

Lawfully detained, institutionalised and patients who are unable to give informed consent due to physical or mental conditions will not be included.

* Intrauterine devices and hormonal contraceptives (oral pills, patches, implants, vaginal rings, and injections) are considered as adequate contraceptives. Females of childbearing potential must use one of these contraceptives throughout the entire study plus 1 week after last injection with study medication. Surgical sterile (by bilateral vasectomy, tubectomy, hysterectomy or oophorectomy) or postmenopausal (defined as amenorrheic for at least one year) female participants are not considered as having a childbearing potential and are not required to use contraception.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The trial will examine the effects of liraglutide treatment on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease. The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT).;Secondary Objective: Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.;Primary end point(s): Difference between the two treatment arms in area under the curve for the plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26.;Timepoint(s) of evaluation of this end point: The trial visit of week 26

Secondary Outcome Measures