The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure (LiRA2)

Bo Feldt-Rasmussen

Status and phase

Withdrawn

Phase 2

Conditions

Prediabetic State

Kidney Failure, Chronic

Treatments

Drug: Liraglutide

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02284230

U1111-1149-7801

Details and patient eligibility

About

The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). 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 objectives include various clinical and biochemical cardiovascular and safety parameters.

We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate other cardiovascular risk factors.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

End-stage renal disease 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

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.